drugset / Trial / NCT05282940
Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product
RandomizedCrossoverOpen-labelBasic science
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.
Timeline
- Start
- 2022-02-26
- Primary completion
- 2022-03-15
- Completion
- 2022-04-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Levonorgestrel | Small molecule | 15 mg | — |
| Comparator | ethinyl estradiol | Small molecule | 0.03 mg | — |
Indications
No indication recorded.