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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Volunteers

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: BIA 2-093
* Drug: Contraceptives, Oral, Combined


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment sequence A<br>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 | Drug: BIA 2-093<br> <br> Drug: Contraceptives, Oral, Combined<br> <br> |
| Other: Treatment sequence B<br>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 | Drug: BIA 2-093<br> <br> Drug: Contraceptives, Oral, Combined<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax - Maximum Observed Plasma BIA 2-194 Concentration | Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily. | Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Cmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference) | pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period. | 
| Tmax | Tmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference) | pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period. | 
| AUC0-t | AUC0-t (ng.h/mL) following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference) | pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period. |