Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Single centre, open-label, randomised study in four parallel groups of healthy volunteers

• 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 45 years, inclusive.

• Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.

• Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, neurological examination, and 12-lead ECG.

• Subjects who had clinical laboratory tests clinically acceptable at screening and admission.

• Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.

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

• Subjects who were non-smokers or who smoke < 10 cigarettes or equivalent per day.

• Subjects who are able and willing to give 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, intrauterine device or abstinence.

• (If female) She had a negative pregnancy test at screening and admission to Phase A.

Exclusion Criteria:

• Subjects who did not conform to the above inclusion criteria, OR

• Subjects who had a 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.

• 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 (especially carbamazepine or oxcarbazepine).

• 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 or admission.