NCT01436513

A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.

Phase 1, Open-Label, Randomized, Single-Dose, Crossover Bioequivalence And Food Effect Study For A New Formulation Of Premarin Compared With A Reference Tablet In Japanese Healthy Postmenopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.

Conditions

• Primary Ovarian Insufficiency
• Vaginitis
• Metrorrhagia
• Menopause

Interventions

Type	Name	Description
DRUG	Premarin reference tablet (fasted)	Premarin reference tablet, single dose, fasted conditions
DRUG	Premarin new tablet (fasted)	Premarin new tablet, single dose, fasted conditions
DRUG	Premarin reference tablet (fed)	Premarin reference tablet, single dose, fed conditions
DRUG	Premarin new tablet (fed)	Premarin new tablet, single dose, fed conditions

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-09-19
• Last updated: 2012-03-15

Locations

1 site across 1 country: Japan