NCT02281448

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	BIA 2-093
DRUG	Contraceptives, Oral, Combined

Timeline

• Start date: 2005-03-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2014-11-03
• Last updated: 2014-12-03
• Results posted: 2014-12-03

Locations

1 site across 1 country: Portugal