drugset / Trial / NCT04230070
Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product
RandomizedCrossoverOpen-labelBasic science
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.
Timeline
- Start
- 2020-10-24
- Primary completion
- 2020-10-31
- Completion
- 2020-11-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levonorgestrel | Small molecule | 15 mg | — |
| Subject | ethinyl estradiol | Small molecule | 0.03 mg | — |
Indications
No indication recorded.