Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Gliclazide in Healthy Volunteers
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A Period 1 - BIA 2-093 + Gliclazide Period 2 - Gliclazide |
Drug: BIA 2-093
Other Names:
Drug: Gliclazide
tablets containing gliclazide 80 mg (Diamicron® 80 mg)
|
| Experimental: Group B Period 1 - Gliclazide Period 2 - BIA 2-093 + Gliclazide |
Drug: BIA 2-093
Other Names:
Drug: Gliclazide
tablets containing gliclazide 80 mg (Diamicron® 80 mg)
|
Outcome Measures
Primary Outcome Measures
- Cmax [before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose]
Maximum plasma concentration (Cmax) of Gliclazide following a single oral dose of 80 mg administered alone
- Tmax [before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose]
Time to maximum observed concentration (Tmax) of Gliclazide following a single oral dose of 80 mg administered alone
- AUC0-12 [before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose]
Area under the plasma concentration-time curve over 12 hours (AUC0-12) of Gliclazide following a single oral dose of 80 mg administered alone
- AUC0-∞ [before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects were eligible for the study if they fulfilled all of the following inclusion criteria:
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Male or female subjects aged between 18 and 45 years, inclusive.
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Body mass index (BMI) between 19 and 30 kg/m2, inclusive.
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Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
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Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
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Clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
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Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
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Non-smokers or who smoke ≤ 10 cigarettes or equivalent per day.
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Able and willing to give written informed consent.
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(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.
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(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:
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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.
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Clinically relevant surgical history.
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History of relevant atopy or drug hypersensitivity.
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History of alcoholism or drug abuse.
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Consumed more than 14 units of alcohol a week.
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Significant infection or known inflammatory process at screening or admission to each treatment period.
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Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
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Used medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion.
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Used any investigational drug or participated in any clinical trial within 6 months prior to screening.
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Participated in more than 2 clinical trials within the 12 months prior to screening.
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Donated or received any blood or blood products within the 3 months prior to screening.
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Vegetarians, vegans or with medical dietary restrictions.
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Could not communicate reliably with the investigator.
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Unlikely to co-operate with the requirements of the study.
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Unwilling or unable to give written informed consent.
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(If female) Pregnant or breast-feeding.
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(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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Human Pharmacology Unit | S. Mamede do Coronado | Portugal | 4745-457 |
Sponsors and Collaborators
- Bial - Portela C S.A.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BIA-2093-126