drugset / Trial / NCT04194905
Bioavailability of Levonorgestrel/Ethinyl Estradiol Tablets 0.1 mg/0.02 mg With Regards to Reference Product
RandomizedCrossoverOpen-labelBasic science
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.
Timeline
- Start
- 2020-11-21
- Primary completion
- 2020-11-21
- Completion
- 2020-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levonorgestrel | Small molecule | 0.1 mg | — |
| Subject | ethinyl estradiol | Small molecule | 0.02 mg | — |
Indications
No indication recorded.