drugset / Trial / NCT06233071
Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets Relative to Yaz®
RandomizedCrossoverOpen-labelBasic science
Summary
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 28 days washout period between the doses.
Timeline
- Start
- 2024-02-13
- Primary completion
- 2024-04-04
- Completion
- 2024-05-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | drospirenone | Unknown | 3 mg | Oral |
| Subject | ethinyl estradiol | Small molecule | 0.02 mg | Oral |
Indications
No indication recorded.