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

NCT ID: NCT02281448

Last Updated: 2014-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2005-05-31

Brief 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

Detailed Description

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 30 μg ethinyloestradiol and 150 μg levonorgestrel on two occasions - once as such and once after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 for 15 days separated by a washout period of at least 3 weeks.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment sequence A

oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive

Group Type: OTHER

BIA 2-093

Intervention Type: DRUG

Contraceptives, Oral, Combined

Intervention Type: DRUG

Treatment sequence B

oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days

Group Type: OTHER

BIA 2-093

Intervention Type: DRUG

Contraceptives, Oral, Combined

Intervention Type: DRUG

Interventions

BIA 2-093

Intervention Type: DRUG

Contraceptives, Oral, Combined

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

BIAL - Portela & Cª, S.A.

S. Mamede Do Coronado, S. Mamede Do Coronado, Portugal

Countries

Portugal

Other Identifiers

BIA-2093-114

Identifier Type: -

Identifier Source: org_study_id