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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.

NCT01436513 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2012-03-15

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Japan

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01436513 on ClinicalTrials.gov