Overview

Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product

Status:
Recruiting
Trial end date:
2022-03-15
Target enrollment:
Participant gender:
Summary
This study will investigate the bioavailability in women of 2 tablet formulations containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The study will be performed at a single site with 36 subjects. Participants will take 2 tablets of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 14 days between each study period.
Phase:
Phase 1
Details
Lead Sponsor:
Laboratorios Andromaco S.A.
Treatments:
Estradiol
Ethinyl Estradiol
Ethinyl Estradiol-Norgestrel Combination
Ethinyl estradiol, levonorgestrel drug combination
Levonorgestrel