Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 40
Healthy volunteers: yes

Brief summary:
The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets under fed conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms:
arm 1: Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg arm 2: Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets

Interventions: intervention 1: Estradiol/Norethindrone acetate intervention 2: Activella®
Intervention descriptions: intervention 1: 1 mg/0.5 mg Tablets intervention 2: 1 mg/0.5 mg Tablets

Protocol document: