Conditions: Healthy
Keywords: Healthy Subjects Bioequivalence
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 22
Healthy volunteers: yes

Brief summary:
The objective of this study is to evaluate the comparative bioavailability between Anastrozole 1 mg Tablets (Teva Pharmaceuticals USA) and Arimidex® 1 mg Tablets (AstraZeneca Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fasting conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms:
arm 1: Anastrozole Tablets, 1 mg arm 2: Arimidex® Tablets, 1 mg

Interventions: intervention 1: Anastrozole (Teva Pharmaceuticals USA) intervention 2: Anastrozole (Arimidex®)
Intervention descriptions: intervention 1: 1 mg Tablets intervention 2: 1 mg Tablets

Protocol document: