Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9 males and 9 females). The study consisted of three consecutive single-dose treatment periods separated by a washout period of 7 days or more. On each treatment period, the volunteers received a single dose of BIA 2-093 800 mg, orally.

• 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 28 kg/m2, inclusive.

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

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

• Subjects who were negative for HBsAg, 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.

• Subjects who were non-smokers or who smoke 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, if of childbearing potential, she used one of the following methods of contraception: doublebarrier, intra-uterine device or abstinence.

• (If female) She had a negative pregnancy test at screening and admission to each study period.

Exclusion Criteria:

• Subjects who do not conform to the above inclusion criteria, or

• Subjects who have 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 have a clinically relevant surgical history.

• Subjects who have a clinically relevant family history.

• Subjects who have a history of relevant atopy.

• Subjects who have a history of any drug hypersensitivity.

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

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

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

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

• Subjects who have used medicines within 2 weeks of admission to first period.

• Subjects who have participated in any clinical trial within 3 months prior to screening.

• Subjects who have previously received BIA 2-093.

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

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

• Subjects who cannot communicate reliably with the investigation team.

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

• Subjects who are unwilling or unable to give written informed consent.

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

• (If female) She is of childbearing potential and she does not use an approved effective contraceptive method or she uses oral contraceptives.