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Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation

2014-08-27 03:32:24 | BioPortfolio

Summary

The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.

Study Design

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

Conditions

Menopause

Intervention

Premarin®/MPA formulation A, Premarin®/MPA formulation B, Premarin®/MPA formulation C, Premarin®/MPA currently marketed product

Status

Completed

Source

Wyeth

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:32:24-0400

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