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Ketoconazole

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41. Ketoconazole does not decrease fungal amount in seborrhoeic dermatitis patients. (PubMed)

Ketoconazole does not decrease fungal amount in seborrhoeic dermatitis patients. 26920094 2017 07 31 2017 08 17 1365-2133 175 2 2016 Aug The British journal of dermatology Br. J. Dermatol. Ketoconazole does not decrease fungal amount in patients with seborrhoeic dermatitis. 417-21 10.1111/bjd.14501 Zani M B MB Centro de Ciências Naturais e Humanas, Universidade Federal do ABC, Santo André, São Paulo, Brazil. Soares R C RC Centro de Ciências Naturais e Humanas, Universidade Federal do ABC, Santo (...) Preparations R9400W927I Ketoconazole IM Administration, Topical Antifungal Agents administration & dosage Back Case-Control Studies Dermatitis, Seborrheic drug therapy microbiology Dermatomycoses drug therapy microbiology Facial Dermatoses drug therapy microbiology Hair Preparations administration & dosage Humans Ketoconazole administration & dosage Malassezia Real-Time Polymerase Chain Reaction Scalp Dermatoses drug therapy microbiology 2016 2 28 6 0 2016 2 28 6 0 2017 8 2 6 0 ppublish 26920094 10.1111

2016 British Journal of Dermatology

42. Exploratory effects of a strong CYP3A inhibitor (ketoconazole), a strong CYP3A inducer (rifampicin), and concomitant ethanol on piragliatin pharmacokinetics and pharmacodynamics in type 2 diabetic patients. (PubMed)

Exploratory effects of a strong CYP3A inhibitor (ketoconazole), a strong CYP3A inducer (rifampicin), and concomitant ethanol on piragliatin pharmacokinetics and pharmacodynamics in type 2 diabetic patients. Piragliatin is a CYP3A substrate; its inactive metabolite M4, formed through cytosolic reductase, is reversibly metabolized back to piragliatin through CYP3A. The impact of concomitant CYP3A modifiers thus cannot be predicted. Drinking alcohol under fasting conditions is associated (...) with a recognized glucose-lowering effect, which might be synergistic with piragliatin's hypoglycemic effect. Two exploratory studies were conducted to examine these potential interactions in type 2 diabetes (T2D) patients: 16 completed an open-label, sequential 2-way crossover, 2-arm (randomized to ketoconazole and rifampicin) CYP3A study; another 18 participated in a double-blind, placebo-controlled, randomized 3-way crossover ethanol study. Administration of piragliatin (100-mg single dose) resulted in a 32

2016 Journal of clinical pharmacology

43. Evaluation of the effect of fluconazole and ketoconazole on the pharmacokinetics of tofacitinib in healthy adult subjects. (PubMed)

Evaluation of the effect of fluconazole and ketoconazole on the pharmacokinetics of tofacitinib in healthy adult subjects. Tofacitinib is a novel, oral JAK inhibitor that is being investigated as a targeted immunomodulator. Tofacitinib is predominantly metabolized by cytochrome P450 (CYP) 3A4 and to a lesser extent by CYP2C19. Two Phase 1, randomized, open-label, single sequence studies in 24 healthy subjects (12 per study) characterized the effects of fluconazole (moderate CYP3A4/potent (...) CYP2C19 inhibitor) and ketoconazole (potent CYP3A4 inhibitor) on tofacitinib pharmacokinetics. In the fluconazole study, subjects received a single tofacitinib 30 mg dose. After 72 hours, subjects received fluconazole 400 mg, followed by 200 mg once daily (QD; days 2-7) plus tofacitinib 30 mg on day 5. In the ketoconazole study, a single tofacitinib 10 mg dose was administered. After 24 hours, subjects received ketoconazole (400 mg QD; days 1-3) plus tofacitinib 10 mg on day 3. Treatment comparisons

2016 Clinical pharmacology in drug development

44. Effects of CYP3A4 Inhibitors Ketoconazole and Verapamil and the CYP3A4 Inducer Rifampicin on the Pharmacokinetic Parameters of Fostamatinib: Results from In Vitro and Phase I Clinical Studies. (PubMed)

Effects of CYP3A4 Inhibitors Ketoconazole and Verapamil and the CYP3A4 Inducer Rifampicin on the Pharmacokinetic Parameters of Fostamatinib: Results from In Vitro and Phase I Clinical Studies. Fostamatinib (R788) is a spleen tyrosine kinase (SYK) inhibitor. The active metabolite of fostamatinib, R406, is primarily metabolized by CYP3A4.The aim of this study was to characterize hepatic microsomal metabolism of R406 and confirm the role of CYP3A4 in R406 metabolism, determining whether co (...) -administration of CYP3A4 inhibitors (ketoconazole, verapamil) or inducers (rifampicin) affects R406 pharmacokinetics.R406 stability was determined using human hepatic microsomes. The CYP450 isoforms responsible for R406 metabolism in humans were identified using expressed CYP450 isoforms and specific chemical inhibitors. The ketoconazole interaction study (double-blind, randomized, placebo-controlled, two-period crossover) involved fostamatinib administration (single 80-mg dose), alone and with ketoconazole

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2016 Drugs in R&D

45. Pharmacokinetic interaction of riociguat with ketoconazole, clarithromycin, and midazolam (PubMed)

Pharmacokinetic interaction of riociguat with ketoconazole, clarithromycin, and midazolam Riociguat is a soluble guanylate cyclase stimulator for the treatment of pulmonary hypertension that is principally metabolized via the cytochrome P450 (CYP) pathway. Three studies in healthy males investigated potential pharmacokinetic interactions between riociguat and CYP inhibitors (ketoconazole, clarithromycin, and midazolam). In two studies, subjects were pretreated with either once-daily (...) ketoconazole 400 mg or twice-daily clarithromycin 500 mg for 4 days before cotreatment with either riociguat 0.5 mg ± ketoconazole 400 mg or riociguat 1.0 mg ± clarithromycin 500 mg. In the third study, subjects received riociguat 2.5 mg 3 times daily (tid) for 3 days, followed by cotreatment with riociguat 2.5 mg tid ± midazolam 7.5 mg. Pharmacokinetic parameters, the effect of smoking on riociguat pharmacokinetics, safety, and tolerability were assessed. Pre- and cotreatment with ketoconazole

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2016 Pulmonary circulation

46. Ketoconazole

Ketoconazole Ketoconazole Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Ketoconazole Ketoconazole Aka: Ketoconazole , Nizoral From (...) Related Chapters II. Precautions Hepatotoxicity risk (FDA black box warning) Oral forumulation indicated only for severe, refractory systemic fungal infections due to Ketoconazole hepatotoxicity No longer indicated in s If Ketoconazole is used, requires s at baseline and again weekly III. Adverse Effects: Oral (systemic formulation) toxicity (Hepatotoxicity) IV. Drug Interactions: Oral (systemic formulation) Serious cardiac arrhythmia with Hismanal or Seldane (off market in U.S.) Multiple other s

2018 FP Notebook

47. Comparative clinical trial: fluconazole alone or associated with topical ketoconazole in the treatment of pityriasis versicolor. (PubMed)

Comparative clinical trial: fluconazole alone or associated with topical ketoconazole in the treatment of pityriasis versicolor. The efficacy of ketoconazole and fluconazole in pityriasis versicolor had been proved.To compare the efficacy and the safety of two doses of fluconazole given 1 week apart alone or associated to ketoconazole shampoo.Our study included all patients with pityriasis versicolor who attended in dermatology department of Habib Thameur Hospital, Tunis (over a 21-month period (...) ). During the considered period, patients were randomly assigned in two study groups: G1 receiving fluconazole two doses 300mg given 1 week apart with G2 taken an association of fluconazole (two doses 300mg given 1 week apart) and ketoconazole shampoo the first day.Seventy one patients were enrolled in our study: 35 in the fluconazole group and 36 in the fluconazole associated to ketoconazole shampoo comparator group. The mean age was 29.1 years [16-70 years].  Concerning the clinical form, 27% had

2016 La Tunisie médicale

48. Comparison of Antimicrobial Activity of Chlorhexidine, Coconut Oil, Probiotics, and Ketoconazole on Candida albicans Isolated in Children with Early Childhood Caries: An In Vitro Study (PubMed)

Comparison of Antimicrobial Activity of Chlorhexidine, Coconut Oil, Probiotics, and Ketoconazole on Candida albicans Isolated in Children with Early Childhood Caries: An In Vitro Study Background. Early childhood caries (ECC) is associated with early colonisation and high levels of cariogenic microorganisms. With C. albicans being one of those, there is a need to determine the effectiveness of various chemotherapeutic agents against it. The study is aimed at isolating Candida species (...) in children with ECC and at studying the antifungal effect of coconut oil, probiotics, Lactobacillus, and 0.2% chlorhexidine on C. albicans in comparison with ketoconazole. Materials and Methods. Samples were collected using sterile cotton swabs, swabbed on the tooth surfaces from children with ECC of 3 to 6 yrs and streaked on Sabouraud dextrose agar (HI Media) plates and incubated in a 5% CO2 enriched atmosphere at 37°C for 24 hours. Candida was isolated and its susceptibility to probiotics

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2016 Scientifica

49. Relative Bioavailability of Single Doses of Dabigatran Etexilate When Administered Alone or in Combination With a Single Dose of Ketoconazole or in Combination With q.d. Ketoconazole at Steady State in Healthy Male and Female Volunteers

Relative Bioavailability of Single Doses of Dabigatran Etexilate When Administered Alone or in Combination With a Single Dose of Ketoconazole or in Combination With q.d. Ketoconazole at Steady State in Healthy Male and Female Volunteers Relative Bioavailability of Single Doses of Dabigatran Etexilate When Administered Alone or in Combination With a Single Dose of Ketoconazole or in Combination With q.d. Ketoconazole at Steady State in Healthy Male and Female Volunteers - Full Text View (...) - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Relative Bioavailability of Single Doses of Dabigatran Etexilate When Administered Alone or in Combination With a Single Dose of Ketoconazole or in Combination With q.d. Ketoconazole at Steady

2014 Clinical Trials

50. Ketoconazole HRA

Ketoconazole HRA 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact 25 September 2014 EMA/CHMP/534845/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report Ketoconazole HRA International non-proprietary name: KETOCONAZOLE HRA Procedure No. EMEA/H/C/003906/0000 Note Assessment report as adopted by the CHMP (...) with all information of a commercially confidential nature deleted. Ketoconazole HRA Assessment report EMA/CHMP/534845/2014 Page 2/115 Table of contents 1. Background information on the procedure 5 1.1. Submission of the dossier 5 1.2. Manufacturers 5 1.3. Steps taken for the assessment of the product 6 2. Scientific discussion 6 2.1. Introduction 6 2.2. Quality aspects 10 2.3. Non-clinical aspects 14 2.4. Clinical aspects 22 2.5. Clinical efficacy 31 2.6. Clinical safety 61 2.7. Pharmacovigilance 79

2014 European Medicines Agency - EPARs

51. Effect of the CYP3A inhibitors, diltiazem and ketoconazole, on ticagrelor pharmacokinetics in healthy volunteers. (PubMed)

Effect of the CYP3A inhibitors, diltiazem and ketoconazole, on ticagrelor pharmacokinetics in healthy volunteers. Two open-label, two-period, crossover studies in healthy volunteers were designed to determine the pharmacokinetic interactions between ticagrelor, a P2Y12 receptor antagonist, and a moderate (diltiazem) and a strong (ketoconazole) cytochrome P450 (CYP) 3A inhibitor.Seventeen volunteers received diltiazem (240 mg once daily) for 14 days. In the second study, ketoconazole (n = 14 (...) ) 200 mg twice daily was given for 10 days. A single oral 90-mg ticagrelor dose was administered on day 8 (diltiazem) or day 4 (ketoconazole). In each study, volunteers received a single 90-mg oral dose of ticagrelor before or after washout (≥14 days). Pharmacokinetic parameters for ticagrelor, AR-C124910XX (primary metabolite), diltiazem, and ketoconazole were assessed.Compared with ticagrelor alone, diltiazem co-administration significantly increased the mean maximum concentration (C max) and mean

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2016 Journal of drug assessment

52. Noncorticosteroid Combination Shampoo versus 1% Ketoconazole Shampoo for the Management of Mild-to-Moderate Seborrheic Dermatitis of the Scalp: Results from a Randomized, Investigator-Single-Blind Trial Using Clinical and Trichoscopic Evaluation. (PubMed)

Noncorticosteroid Combination Shampoo versus 1% Ketoconazole Shampoo for the Management of Mild-to-Moderate Seborrheic Dermatitis of the Scalp: Results from a Randomized, Investigator-Single-Blind Trial Using Clinical and Trichoscopic Evaluation. The aim of this study was to assess the efficacy and tolerability of a combination noncorticosteroid, antiinflammatory/antifungal shampoo versus 1% ketoconazole shampoo in the treatment of mild-to-moderate scalp seborrheic dermatitis (SD).Twenty (...) patients were randomized to using the combination shampoo (group A, 10 patients) or the 1% ketoconazole shampoo (group B, 10 patients) 3 times a week every other day for 8 weeks. Efficacy was evaluated by measuring the degree of scaling and pruritus by clinical and trichoscopic examination using a 4-point scale. Additionally, a physician global assessment (PGA) was assessed at the end of the study.At 4 weeks, there was a significant reduction of scaling from baseline for both groups, while pruritus

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2016 Skin appendage disorders

53. Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis

Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please (...) remove one or more studies before adding more. Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis (DaVinci) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT02582177

2015 Clinical Trials

54. Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis

Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum (...) number of saved studies (100). Please remove one or more studies before adding more. Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02606383 Recruitment Status : Withdrawn First

2015 Clinical Trials

55. Evaluation of Cytochrome P450 (CYP) 3A4-Based Interactions of Levomilnacipran with Ketoconazole, Carbamazepine or Alprazolam in Healthy Subjects. (PubMed)

Evaluation of Cytochrome P450 (CYP) 3A4-Based Interactions of Levomilnacipran with Ketoconazole, Carbamazepine or Alprazolam in Healthy Subjects. Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor with balanced potency for the reuptake inhibition of norepinephrine and serotonin, approved in the USA for the treatment of major depressive disorder (MDD) in adults. We conducted studies in healthy human subjects to investigate pharmacokinetic interactions when levomilnacipran (...) extended-release (ER) is administered in combination with an inhibitor (ketoconazole), an inducer (carbamazepine), or a substrate (alprazolam) of cytochrome P450 (CYP) 3A4.Randomised, open-label studies were conducted in healthy volunteers (n = 34 ketoconazole, n = 34 carbamazepine, n = 30 alprazolam) and pharmacokinetic parameters were determined when levomilnacipran was administered alone or together with the relevant study drug.Co-administration of ketoconazole with levomilnacipran ER increased

2015 Clinical drug investigation

56. Flea (Ctenocephalides felis) control efficacy of topical indoxacarb on dogs subsequently bathed with a chlorhexidine-ketoconazole shampoo. (PubMed)

Flea (Ctenocephalides felis) control efficacy of topical indoxacarb on dogs subsequently bathed with a chlorhexidine-ketoconazole shampoo. An evaluation of the effect of chlorhexidine/ketoconazole shampoo baths on the flea control efficacy of indoxacarb applied topically to dogs.We randomly allocated 18 healthy mixed-breed dogs to 3 groups: shampoo only; indoxacarb treated and medicated shampoo; and indoxacarb treated but not shampooed. Indoxacarb was administered on day 0 and dogs were

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2015 Australian veterinary journal

57. Pharmacokinetic interaction between the CYP3A4 inhibitor ketoconazole and the hormone drospirenone in combination with ethinylestradiol or estradiol. (PubMed)

Pharmacokinetic interaction between the CYP3A4 inhibitor ketoconazole and the hormone drospirenone in combination with ethinylestradiol or estradiol. The present study was conducted to investigate the influence of the strong CYP3A4 inhibitor ketoconazole (KTZ) on the pharmacokinetics of drospirenone (DRSP) administered in combination with ethinylestradiol (EE) or estradiol (E2).This was a randomized, multicentre, open label, one way crossover, fixed sequence study with two parallel treatment

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2015 British journal of clinical pharmacology

58. Pharmacokinetic interaction of intravenous fentanyl with ketoconazole. (PubMed)

Pharmacokinetic interaction of intravenous fentanyl with ketoconazole. Fentanyl is primarily metabolized by CYP3A, but has also been suggested to act as a weak inhibitor of CYP3A. We investigated the influence of CYP3A inhibition by ketoconazole on the pharmacokinetics of intravenously administered fentanyl and the effect of fentanyl on CYP3A activity. A prospective, open-label, randomized, monocentre, crossover study was conducted in 16 healthy volunteers. They received fentanyl alone (5 (...)  microgram per kilogram) or fentanyl plus ketoconazole (200 milligram orally B.I.D. over 2 days). Naloxone (2 × 0.2 milligram i.v.) was given simultaneously with fentanyl to mitigate any opioid effect. Midazolam was administered as a CYP3A probe drug. Fentanyl and its metabolites were quantified by LC/MS/MS in blood and urine samples obtained over 24 hour. Exposure of fentanyl (AUC0- ∞ ) was significantly increased to 133% and systemic clearance was reduced to 78% by ketoconazole, norfentanyl formation

2015 Journal of clinical pharmacology

59. A randomized double-blind, non-inferiority Phase II trial, comparing dapaconazole tosylate 2% cream with ketoconazole 2% cream in the treatment of Pityriasis versicolor. (PubMed)

A randomized double-blind, non-inferiority Phase II trial, comparing dapaconazole tosylate 2% cream with ketoconazole 2% cream in the treatment of Pityriasis versicolor. The objective of this research was to evaluate the efficacy of a new antifungal imidazole, dapaconazole tosylate, in the treatment of Pityriasis versicolor (PV).Sixty patients with clinical and mycological diagnosis of PV were randomly assigned to receive either 1 g dapaconazole tosylate 2% cream or 1 g ketoconazole 2% cream (...) with ketoconazole and dapaconazole, respectively (difference [effect size] = 8.0%, Standard error of difference: 8.69%, 95% CI: -6.3 to 22.3%). Median time to healing was 23.5 and 21 days for ketoconazole and dapaconazole, respectively (p = 0.126). Adverse events occurred only in ketoconazole-treated patients (13%; 4/30).Dapaconazole tosylate is non-inferior to ketoconazole when used at a dose of 20 mg/day for 28 consecutive days for the treatment of PV. Dapaconazole also demonstrated a good safety profile.

2015 Expert Opinion on Investigational Drugs

60. Topical 5% Natamycin With Oral Ketoconazole in Filamentous Fungal Keratitis: A Randomized Controlled Trial. (PubMed)

Topical 5% Natamycin With Oral Ketoconazole in Filamentous Fungal Keratitis: A Randomized Controlled Trial. To assess the role of additive oral antifungal therapy in deep keratitis caused by filamentous fungi.A randomized, masked, double-blind clinical trial.All patients presenting with culture-positive fungal keratitis with a size measuring 2 to 60 mm2 and involving more than 50% of stromal depth were enrolled in 1 of the 2 treatment arms. Group A received 5% natamycin, whereas Group B (...) was given 200mg of oral ketoconazole twice a day in addition to 5% natamycin. Patients were followed up for 4 weeks. Liver function was assessed at baseline and at exit. Tests for significance included t test to compare the means of continuous variables, chi-square and Fisher's exact tests for comparing categorical variables and Kaplan-Meier procedure to estimate the survival rate.Of the 115 patients enrolled, 108 completed the study. Fifty-eight patients were in group A and 57 in group B

2015 Asia-Pacific journal of ophthalmology (Philadelphia, Pa.)

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