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Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fasting Conditions

2014-08-27 03:19:30 | BioPortfolio

Summary

The objective of this study is to compare the rate and extent of absorption of bicalutamide 50 mg tablets (test) versus Casodex® (reference) administered as 1 x 50 mg tablet under fasting conditions.

Description

This will be a single center, bioequivalence, open-label, randomized, 1-way parallel study.

According to the BA/BE guidances, a parallel study is acceptable for drugs with a long half-life.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label

Conditions

Healthy

Intervention

Bicalutamide, Casodex®

Location

Anapharm Inc.
Sainte-Foy
Quebec
Canada
G1V 2K8

Status

Completed

Source

Teva Pharmaceuticals USA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:30-0400

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