Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01182207 | Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 33 | — | — | Jul 1, 2006 | Aug 1, 2006 | Dec 8, 2010 | 1 | United States |
| NCT01182194 | Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Fasting Conditions. | PHASE1 | COMPLETED | 32 | — | — | Jun 1, 2006 | Aug 1, 2006 | Dec 8, 2010 | 1 | United States |
Bioequivalence based on Drospirenone Cmax.
Bioequivalence based on Drospirenone AUC0-t.
Bioequivalence based on Drospirenone AUC0-inf.
Bioequivalence based on Ethinyl Estradiol Cmax.
Bioequivalence based on Ethinyl Estradiol AUC0-t.
Bioequivalence based on Ethinyl Estradiol AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| Investigational Test Product | EXPERIMENTAL | Drospirenone/Ethinyl Estradiol Tablets, 3 mg/0.02 mg |
| Reference Listed Drug | ACTIVE_COMPARATOR | YAZ® Tablets, 3 mg/0.02 mg |
| Name | Type | Description |
|---|---|---|
| Drospirenone/Ethinyl Estradiol (Gianvi®) | DRUG | 3 mg/0.02 mg Tablets |
| YAZ® | DRUG | 3 mg/0.02 mg Tablets |
Inclusion Criteria: * Subjects who were informed of the nature of the study and agreed to read, review, and sign the informed consent document prior to Period I dosing. * Subjects who completed the screening process within 28 days prior to Period I dosing. * Subjects who were healthy, adult, menstr...