Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 32
Healthy volunteers: yes

Brief 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.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Arms:
arm 1: Drospirenone/Ethinyl Estradiol Tablets, 3 mg/0.02 mg arm 2: YAZ® Tablets, 3 mg/0.02 mg

Interventions: intervention 1: Drospirenone/Ethinyl Estradiol (Gianvi®) intervention 2: YAZ®
Intervention descriptions: intervention 1: 3 mg/0.02 mg Tablets intervention 2: 3 mg/0.02 mg Tablets

Protocol document: