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.

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Estrogens; Estrogens, Conjugated (USP)

Criteria

Inclusion Criteria:

• Japanese healthy postmenopausal women

Exclusion Criteria:

• History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies.

• History or presence of malignancy or estrogen-dependent neoplasia. Subjects with a documented history of any malignancy, except for basal or squamous cell carcinoma of skin, which has been treated and fully resolved for a minimal 5 years.

• History or presence of benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products.