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Eslicarbazepine

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221. Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive

Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive - 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. Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive 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: NCT00898560 Recruitment Status : Completed First Posted : May 12

2009 Clinical Trials

222. Effect of eslicarbazepine acetate on the pharmacokinetics of metformin in healthy subjects. (Abstract)

Effect of eslicarbazepine acetate on the pharmacokinetics of metformin in healthy subjects. Eslicarbazepine acetate (ESL) is a new voltage-gated sodium channel blocker currently in development for the treatment of neuropathic pain, including that of diabetic origin. The primary objective was to investigate the effect of ESL on the pharmacokinetics of metformin, a commonly used oral antidiabetic drug.Randomized, open-label, two-way crossover study in 20 healthy subjects. The volunteers received

2009 International journal of clinical pharmacology and therapeutics Controlled trial quality: uncertain

223. Effect of eslicarbazepine acetate on the pharmacokinetics of digoxin in healthy subjects. (Abstract)

Effect of eslicarbazepine acetate on the pharmacokinetics of digoxin in healthy subjects. Eslicarbazepine acetate (ESL) is a new-generation voltage-gated sodium channel blocker, which has been demonstrated to be effective and well tolerated in the treatment of epilepsy. The primary objective of this study was to investigate the effect of ESL on the pharmacokinetics of digoxin. This study was a randomized, double-blind, placebo-controlled, two-way crossover study of 12 healthy subjects (six men

2009 Fundamental & clinical pharmacology Controlled trial quality: predicted high

224. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: a randomized, double-blind, placebo-controlled, parallel-group phase III study. (Abstract)

Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: a randomized, double-blind, placebo-controlled, parallel-group phase III study. To study the efficacy and safety of eslicarbazepine acetate (ESL) as adjunctive therapy for refractory partial seizures in adults with >or=4 partial-onset seizures (simple or complex, with or without secondary generalization) per 4 weeks despite treatment with 1-2 antiepileptic drugs (AEDs

2009 Epilepsia Controlled trial quality: predicted high

225. Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures. (Abstract)

Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures. To evaluate the efficacy and safety of eslicarbazepine acetate (ESL) as adjunctive therapy in adults with partial-onset seizures.Double-blind, placebo-controlled, parallel-group, multicenter study consisting of an 8-week baseline period, after which patients were randomized to placebo (n = 87) or once-daily ESL 800 mg (n = 85) or 1200 mg (n = 80). Patients

2009 Acta neurologica Scandinavica Controlled trial quality: uncertain

226. Therapeutic Drug Monitoring

. There are several categories of drugs that require monitoring, as summarised here. Drug Category Drugs Treatment Use Cardiac drugs , digitoxin, amiodarone , , Antibiotics Aminoglycosides (gentamicin, tobramycin, amikacin, , chloramphenicol) Infections with bacteria that are resistant to less powerful antibiotics Antiepileptics , , , , (rarely: ethosuximide, gabapentin, lamotrigine, levetiracetam, topiramate, zonisamide, eslicarbazepine, felbamate, lacosamide, oxcarbazepine, pregabalin, rufinamide, stiripentol

2004 Lab Tests Online UK

227. Contraception and Special Groups

: rifampicin and rifabutin. Anti-epileptics: carbamazepine, eslicarbazepine, phenytoin, phenobarbital, primidone, oxcarbazepine, topiramate. Central nervous system stimulant: modafinil. Antiretroviral drugs: nelfinavir, nevirapine, ritonavir. St John's wort. Combined hormonal contraception COC pill - all women should be advised to switch to a contraceptive method unaffected by enzyme inducers (eg, progestogen-only injectable, copper intrauterine device (Cu-IUCD) or LNG-IUS). Rifampicin and rifabutin

2008 Mentor

228. Combined Oral Contraceptive (Follow-up and Common Problems)

to show any evidence that significant weight gain is a side-effect of the pill. [ ] Interactions [ , , ] There are many commonly used medications which can affect the efficacy of the pill: Antibacterials - enzyme inducers only (eg, rifampicin, rifabutin). Antidepressants - St John's wort (which can be bought over-the-counter). Anticonvulsants - carbamazepine, oxcarbazepine, eslicarbazepine, phenobarbital, phenytoin, primidone and topiramate, due to their enzyme-inducing activity. Also lamotrigine

2008 Mentor

229. Anticonvulsants used for Partial Seizures

, levetiracetam, oxcarbazepine, sodium valproate, perampanel or topiramate as adjunctive treatment if first-line treatments are ineffective or not tolerated. Other AEDs that may be considered by the tertiary epilepsy specialist are eslicarbazepine acetate, lacosamide, phenobarbital, phenytoin, pregabalin, tiagabine, vigabatrin and zonisamide. NB : carefully consider the risk:benefit ratio when using vigabatrin because of the risk of an irreversible effect on visual fields. Interactions [ ] Interactions

2008 Mentor

230. Anticonvulsants used for Generalised Seizures

are eslicarbazepine acetate, lacosamide, phenobarbital, phenytoin, pregabalin, tiagabine, vigabatrin and zonisamide. Idiopathic generalised epilepsy (IGE) First-line treatment: offer sodium valproate as first-line treatment, particularly if there is a photo-paroxysmal response on EEG. Offer lamotrigine if sodium valproate is unsuitable or not tolerated. Lamotrigine can exacerbate myoclonic seizures. Consider topiramate but it has a less favourable side-effect profile than sodium valproate and lamotrigine

2008 Mentor

231. Temporal Lobe Epilepsy

valproate should be considered if carbamazepine and lamotrigine are unsuitable or not tolerated. Adjunctive treatment: offer carbamazepine, clobazam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, sodium valproate or topiramate as adjunctive treatment if first-line treatments are ineffective or not tolerated. Other anti-epileptic drugs (AEDs) that may be considered by the tertiary epilepsy specialist are eslicarbazepine acetate, lacosamide, phenobarbital, phenytoin, pregabalin, tiagabine

2008 Mentor

232. Pill Questions - What to Ask When Starting the OCP.

with special needs. For information on guidelines surrounding prescribing for girls under the age of 16, see the separate article. Interactions [ , , ] There are many commonly used medications which can affect the efficacy of the pill: Antibacterials - enzyme inducers only - eg, rifampicin, rifabutin. Antidepressants - St John's wort (which can be bought over-the-counter). Anticonvulsants - carbamazepine, oxcarbazepine, eslicarbazepine, phenobarbital, phenytoin, primidone and topiramate due to their enzyme

2008 Mentor

233. Eslicarbazepine acetate: a double-blind, add-on, placebo-controlled exploratory trial in adult patients with partial-onset seizures. (Abstract)

Eslicarbazepine acetate: a double-blind, add-on, placebo-controlled exploratory trial in adult patients with partial-onset seizures. To explore the efficacy and safety of eslicarbazepine acetate (BIA 2-093), a new antiepileptic drug, as adjunctive therapy in adult patients with partial epilepsy.A multicenter, double-blind, randomized, placebo-controlled study was conducted in 143 refractory patients aged 18-65 years with >or=4 partial-onset seizures/month. The study consisted of a 12-week (...) treatment period followed by a 1-week tapering off. Patients were randomly assigned to one of three groups: treatment with eslicarbazepine acetate once daily (QD, n=50), twice daily (BID, n=46), or placebo (PL, n=47). The daily dose was titrated from 400 mg to 800 mg and to 1,200 mg at 4-week intervals. The proportion of responders (patients with a >or=50% seizure reduction) was the primary end point.The percentage of responders versus baseline showed a statistically significant difference between QD

2007 Epilepsia Controlled trial quality: predicted high

234. Effect of food on the pharmacokinetic profile of eslicarbazepine acetate (BIA 2-093). (Abstract)

Effect of food on the pharmacokinetic profile of eslicarbazepine acetate (BIA 2-093). To investigate the effect of food on the pharmacokinetics of eslicarbazepine acetate (BIA 2-093), a new voltage-gated sodium channel antagonist.Single-centre, open-label, randomised, two-way crossover study in 12 healthy subjects. The study consisted of two consecutive treatment periods separated by a washout of 14 days or more. In each of the study periods subjects were administered a single dose (...) of eslicarbazepine acetate 800 mg following either a standard high-fat content meal or 10 hours of fasting.Eslicarbazepine acetate was rapidly and extensively metabolised to BIA 2-005. Maximum BIA 2-005 plasma concentrations (C(max)) in fed (test) and fasting (reference) conditions were, respectively, 12.8 +/- 1.8 microg/mL and 11.3 +/- 1.9 microg/mL, and the areas under the plasma concentration time curve from 0 to infinity (AUC(infinity)) were, respectively, 242.5 +/- 32.1 microg.h/mL and 243.6 +/- 31.1

2005 Drugs in R&D Controlled trial quality: uncertain

235. Eslicarbazepine acetate (BIA 2-093) : relative bioavailability and bioequivalence of 50 mg/mL oral suspension and 200mg and 800mg tablet formulations. (Abstract)

Eslicarbazepine acetate (BIA 2-093) : relative bioavailability and bioequivalence of 50 mg/mL oral suspension and 200mg and 800mg tablet formulations. To investigate the bioavailability and bioequivalence of three different formulations of eslicarbazepine acetate (BIA 2-093): 50 mg/mL oral suspension (test 1), 200mg tablets (test 2) and 800mg tablets (reference).Single-centre, open-label, randomised, three-way crossover study in 18 healthy subjects. The study consisted of three consecutive (...) periods separated by a washout period of 7 days or more. Each subject received a single dose of eslicarbazepine acetate 800mg on three different occasions: 16mL of oral 50 mg/mL suspension, four 200mg tablets or one 800mg tablet.Eslicarbazepine acetate was rapidly and extensively metabolised to BIA 2-005. Maximum BIA 2-005 plasma concentrations (Cmax) and area under the plasma concentration-time curve from time 0 to infinity (AUCinfinity) were, respectively (arithmetic mean +/- SD), 18.0 +/- 4.6

2005 Drugs in R&D Controlled trial quality: uncertain

236. Dosage form proportionality and food effect of the final tablet formulation of eslicarbazepine acetate: randomized, open-label, crossover, single-centre study in healthy volunteers. (Abstract)

Dosage form proportionality and food effect of the final tablet formulation of eslicarbazepine acetate: randomized, open-label, crossover, single-centre study in healthy volunteers. To investigate the dosage form proportionality and food effect of the final tablet formulation of eslicarbazepine acetate (ESL) in healthy volunteers.This was a randomized, three-way crossover, single-centre study in 18 healthy volunteers. Subjects received a single dose of oral ESL 800 mg following a standard meal (...) )) geometric means ratios (GMRs) of BIA 2-005, the enantiomeric mixture of the ESL active metabolite eslicarbazepine and its enantiomer R-licarbazepine. Bioequivalence was assumed when the 90% CI of the test/reference GMR fell within the bioequivalence acceptance interval (80.00, 125.00).Following a single dose of ESL 800 mg in the forms of two 400 mg tablets and one 800 mg tablet, the test/reference GMR (%) and 90% CI for C(max), AUC(t) and AUC(infinity) were 100.78% (93.91, 108.16), 100.37% (97.82

2008 Drugs in R&D Controlled trial quality: uncertain

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