Single-dose and Steady-state Pharmacokinetics of BIA 2-093 and Its Metabolites

• Status: Completed
• Trial end date: 2002-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effects of age on the pharmacokinetic profile of BIA 2-093 and its active metabolites.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• Male or female subjects aged between 18 and 40 years, inclusive OR male or female subjects aged 65 years or more.

• If young, subjects who were within 15% of ideal body weight OR, if elderly, subjects who were within 20% of ideal body weight according to the Metropolitan Life Insurance Table.

• 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 to the Investigator.

• Subjects who were negative for HBsAg, HCVAb and 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 give written informed consent.

• (If female) She was not of childbearing potential by reason of surgery or menopause or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine.

• (If female and with less than 40 years old) 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 respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.

• Subjects who had a clinically relevant surgical history.

• Subjects who had a clinically relevant family history.

• Subjects who had a history of relevant atopy.

• Subjects who had a history of relevant drug hypersensitivity.

• Subjects who had a history of alcoholism or drug abuse.

• Subjects who consumed more than 14 units of alcohol a week.

• 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 drugs 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 BIA 2-093.

• Subjects who had donated and/or received any blood or blood products within the previous 2 months prior to screening.

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

• Subjects who could not 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 give written informed consent.

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

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