Status:
COMPLETED
Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Epilepsy
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
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 dail...
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 ethinyloestradio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02281448
Start Date
March 1 2005
End Date
May 1 2005
Last Update
December 3 2014
Active Locations (1)
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1
BIAL - Portela & Cª, S.A.
S. Mamede Do Coronado, S. Mamede Do Coronado, Portugal, 4045-457