Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Non-Fasting Conditions
Summary
This study was designed to compare the relative bioavailability (rate and extent of absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablets) in healthy, adult subjects under non-fasting conditions.
Timeline
- Start
- 2006-07
- Primary completion
- 2006-08
- Completion
- 2006-08
Outcome
Met primary endpoint
registry Ratio of the T/R geometric mean x 100 96.74 (90% CI 86.82 to 107.79) NCT01182207 ↗
registry Ratio of the T/R geometric mean x 100 103.16 (90% CI 101.10 to 105.27) NCT01182207 ↗
registry Ratio of the T/R geometric mean x 100 102.72 (90% CI 100.67 to 104.80) NCT01182207 ↗
registry Ratio of the T/R geometric mean x 100 97.60 (90% CI 89.45 to 106.50) NCT01182207 ↗
registry Ratio of the T/R geometric mean x 100 98.88 (90% CI 95.62 to 102.25) NCT01182207 ↗
registry Ratio of the T/R geometric mean x 100 98.20 (90% CI 95.36 to 101.12) NCT01182207 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Drospirenone/Ethinyl Estradiol | Unknown | 0.02 mg | Oral |
| Subject | Drospirenone/Ethinyl Estradiol | Unknown | 3 mg | Oral |
Indications
No indication recorded.