The Effect of BIA 2-093 on the Steady-state Pharmacokinetic Profile of Phenytoin in Patients

• Status: Terminated
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is determine the interaction of eslicarbazepine acetate (ESL, BIA 2-093) on the steadystate pharmacokinetics of phenytoin in patients and to evaluate the tolerability and safety of ESL administered concomitantly with phenytoin in patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Eslicarbazepine acetate; Phenytoin

Criteria

Inclusion Criteria:

• Male or female subjects aged between 18 and 65 years, inclusive.

• Subjects who were on an established regimen of phenytoin monotherapy, which had been stable for at least 3 months.

• Subjects who had clinical laboratory tests acceptable to the Investigator.

• Subjects who were negative for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody (Ab) and human immunodeficiency viruses (HIV-1 and HIV-2) Ab tests at screening.

• Subjects who were negative for alcohol and drugs of abuse at screening.

• Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.

• Subjects who were able and willing to gave written informed consent.

• (If female) She was 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) She had a negative pregnancy test at screening.

Exclusion Criteria:

• Subjects who did not conform to the above inclusion criteria.

• Subjects who had a clinically relevant history or presence of any disease that may interfere with the pharmacokinetics or pharmacodynamics of the Investigational Products, or may affect its safety.

• Subjects who had a history of relevant drug hypersensitivity.

• Subjects who had a history of alcoholism or drug abuse in the last 2 years.

• Subjects who consumed more than 21 units of alcohol a week.

• Subjects who had one of the following findings on the electrocardiogram (ECG): sinus bradycardia, sinoatrial block, atrioventricular block of any degree.

• Subjects who had a significant infection or known inflammatory process on screening and/or admission.

• Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).

• Subjects who had used any drugs (other than phenytoin) that may affect the pharmacokinetic profile of the investigational products within 2 weeks of first dosing.

• Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to this study.

• Subjects who had previously received ESL.

• Subjects who had donated and/or received any blood or blood products within the previous 3 months prior to screening.

• Subjects who were vegetarians, vegans and/or have medical dietary restrictions.

• Subjects who cannot communicate reliably with the investigator.

• Subjects who were unlikely to co-operate with the requirements of the study.

• Subjects who were unwilling or unable to gave written informed consent.

• (If female) She was pregnant or breast-feeding.

• (If female) She was of childbearing potential and she did not use an approved effective contraceptive method.