drugset / Trial / NCT04193852
Bioavailability of Dienogest and Ethinyl Estradiol Tablets 2.0 mg/0.03 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 Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg. The Pilot study will be performed at a single site with 10 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
- 2019-11-09
- Primary completion
- 2019-11-12
- Completion
- 2019-11-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dienogest | Small molecule | 2 mg | — |
| Subject | ethinyl estradiol | Small molecule | 0.03 mg | — |
Indications
No indication recorded.