Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under 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 tablet) in healthy, adult subjects administered under fasting conditions.
Timeline
- Start
- 2006-06
- Primary completion
- 2006-08
- Completion
- 2006-08
Outcome
Met primary endpoint
registry Ratio of the T/R geometric mean x 100 92.50 (90% CI 85.53 to 100.03) NCT01182194 ↗
registry Ratio of the T/R geometric mean x 100 98.76 (90% CI 95.66 to 101.96) NCT01182194 ↗
registry Ratio of the T/R geometric mean x 100 98.47 (90% CI 95.35 to 101.70) NCT01182194 ↗
registry Ratio of the T/R geometric mean x 100 101.45 (90% CI 94.36 to 109.08) NCT01182194 ↗
registry Ratio of the T/R geometric mean x 100 98.54 (90% CI 94.55 to 102.71) NCT01182194 ↗
registry Ratio of the T/R geometric mean x 100 99.70 (90% CI 96.07 to 103.46) NCT01182194 ↗
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.