Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

Inclusion Criteria

• •Male or female subjects aged between 18 and 45 years, inclusive.
• •Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
• •Subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ECG.
• •Subjects who had clinical laboratory tests acceptable.
• •Subjects who were negative for HBs Ag, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
• •Subjects who were negative for alcohol and drugs of abuse at screening and admission.
• •Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.
• •Subjects who were able and willing to give written informed consent.
• •In case of female volunteers, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, used one of the following methods of contraception: double-barrier, intrauterine device or abstinence.
• •In case of female volunteers, subjects who had a negative pregnancy test at screening and admission
• +20 more criteria