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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02281448
• Other study ID #: BIA-2093-114
• Status: Completed
• Phase: Phase 1
• First received: October 30, 2014
• Last updated: November 28, 2014
• Start date: March 2005
• Est. completion date: May 2005

Study information

• Verified date: November 2014
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: INFARMED, National Authority of Medicines and Health Products, IP
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• BIA 2-093

• Contraceptives, Oral, Combined

Locations

Country	Name	City	State
Portugal	BIAL - Portela & Cª, S.A.	S. Mamede do Coronado

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No