Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Gliclazide in Healthy Volunteers

Study Overview
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Brief Summary
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Single centre, randomised, open-label, two-way crossover study to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) affects the pharmacokinetics of gliclazide.

Official Title
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Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Gliclazide in Healthy Volunteers

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: BIA 2-093
* Drug: Gliclazide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects were eligible for the study if they fulfilled all of the following inclusion criteria: Male or female subjects aged between 18 and 45 years, inclusive. Body mass index (BMI) between 19 and 30 kg/m2, inclusive. Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG. Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening Clinical laboratory test results clinically acceptable at screening and admission to each treatment period. Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period. Non-smokers or who smoke ≤ 10 cigarettes or equivalent per day. Able and willing to give written informed consent. (If female) Not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device. (If female) Negative urine pregnancy test at screening and admission to each treatment period. Exclusion Criteria: Subjects were not eligible for the study if they fulfilled any of the following exclusion criteria: Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders. Clinically relevant surgical history. History of relevant atopy or drug hypersensitivity. History of alcoholism or drug abuse. Consumed more than 14 units of alcohol a week. Significant infection or known inflammatory process at screening or admission to each treatment period. Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period. Used medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion. Used any investigational drug or participated in any clinical trial within 6 months prior to screening. Participated in more than 2 clinical trials within the 12 months prior to screening. Donated or received any blood or blood products within the 3 months prior to screening. Vegetarians, vegans or with medical dietary restrictions. Could not communicate reliably with the investigator. Unlikely to co-operate with the requirements of the study. Unwilling or unable to give written informed consent. (If female) Pregnant or breast-feeding. (If female) Of childbearing potential and she did not use an approved effective contraceptive method (double-barrier or intra-uterine device) or she used oral contraceptives.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Period 1 - BIA 2-093 + Gliclazide Period 2 - Gliclazide | Drug: BIA 2-093<br> <br> * Other names: ESL, Eslicarbazepine acetate;Drug: Gliclazide<br>* tablets containing gliclazide 80 mg (Diamicron® 80 mg)<br>|
| Experimental: Group B<br>Period 1 - Gliclazide Period 2 - BIA 2-093 + Gliclazide | Drug: BIA 2-093<br> <br> * Other names: ESL, Eslicarbazepine acetate;Drug: Gliclazide<br>* tablets containing gliclazide 80 mg (Diamicron® 80 mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum plasma concentration (Cmax) of Gliclazide following a single oral dose of 80 mg administered alone | before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose | 
| Tmax | Time to maximum observed concentration (Tmax) of Gliclazide following a single oral dose of 80 mg administered alone | before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose | 
| AUC0-12 | Area under the plasma concentration-time curve over 12 hours (AUC0-12) of Gliclazide following a single oral dose of 80 mg administered alone | before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose | 
| AUC0-∞ | Area under the concentration-time curve from time zero up to infinity with extrapolation of the terminal phase (AUC0-∞) of Gliclazide following a single oral dose of 80 mg administered alone | before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose |