Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product
Status:
Completed
Trial end date:
2020-11-17
Target enrollment:
Participant gender:
Summary
This Pivotal study will investigate the bioavailability in women of 2 tablet formulations
containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The Pivotal 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.