Overview

Bioavailability of Levonorgestrel/Ethinyl Estradiol Tablets 0.1 mg/0.02 mg With Regards to Reference Product

Status:
Completed
Trial end date:
2020-12-15
Target enrollment:
Participant gender:
Summary
This Pilot study will investigate the bioavailability in fasting women of 2 tablet formulations containing Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg. The Pilot study will be performed at a single site with 30 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
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Ethinyl Estradiol
Ethinyl estradiol, levonorgestrel drug combination
Levonorgestrel
Polyestradiol phosphate