Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Single centre, two-way crossover, randomised, open-label study in 20 healthy female volunteers.The volunteers received an oral single-dose of a combined contraceptive containing with an oral once daily dose of 1200 mg of BIA 2-093

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

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Eslicarbazepine acetate

Criteria

Inclusion Criteria:

• Pre-menopausal female;

• Able and willing to give written informed consent;

• Aged 18 to 40 years, inclusive;

• Not pregnant or breast-feeding;

• Body mass index (BMI) between 19 and 30 kg/m2, inclusive;

• Healthy as determined by medical history, physical examination, complete neurological examination, vital signs, and 12-lead ECG;

• Clinical laboratory tests with clinically acceptable results at screening and admission to the first period;

• Negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening;

• Negative test for drugs of abuse at screening;

• Non-smoker or smokes less than 10 cigarettes or equivalent per day;

• Agreed to either practice abstinence or use a double-barrier or intra-uterine device from screening until the follow-up visit;

• Negative pregnancy test at screening and admission to the first period.

Exclusion Criteria:

• Had any contra-indication to the use of oral contraceptives;

• Had experienced notable adverse events while on any oral contraceptive;

• Had a history of alcoholism or drug abuse;

• Had a relevant history or presence of respiratory, gastrointestinal, renal, hepatic,haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;

• Had acute gastrointestinal symptoms at the time of screening or admission to the first period;

• Had a significant infection or inflammatory process at the time of screening or admission to the first period;

• Had a relevant surgical history;

• Had a relevant family history;

• Had a history of relevant drug hypersensitivity (e.g., carbamazepine or oxcarbazepine);

• Had used relevant prescription or over-the-counter medication within 2 weeks ofadmission to the first period;

• Consumed more than 14 units of alcohol a week;

• Had participated in any clinical trial within 3 months prior to screening;

• Had previously received BIA 2-093;

• Had donated or received any blood or blood products within 2 months prior to screening;

• Was unlikely to co-operate with the requirements of the study.