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.

Pfizer

Status and phase: Completed; Phase 1

Conditions: Metrorrhagia; Menopause; Vaginitis; Primary Ovarian Insufficiency

Treatments: Drug: Premarin new tablet (fasted); Drug: Premarin new tablet (fed); Drug: Premarin reference tablet (fasted); Drug: Premarin reference tablet (fed)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01436513

3117X3-1112

B2811002

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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72 participants in 4 patient groups

A

Experimental group

Description:

Premarin reference tablet as a single oral dose under fasted conditions

Treatment:

Drug: Premarin reference tablet (fasted)

B

Experimental group

Description:

Premarin new tablet as a single oral dose under fasted conditions

Treatment:

Drug: Premarin new tablet (fasted)

C

Experimental group

Description:

Premarin reference tablet as a single oral dose under fed conditions

Treatment:

Drug: Premarin reference tablet (fed)

D

Experimental group

Description:

Premarin new tablet as a single oral dose under fed conditions

Treatment:

Drug: Premarin new tablet (fed)