Study Evaluating Premarin and Bazedoxifene Potential Interaction

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of bazedoxifene (BZA) 20 mg tablet when administered together with multiple doses of Premarin (conjugated estrogens or CE) to healthy postmenopausal women.

Information will also be obtained regarding the safety and tolerability of this combination in healthy, postmenopausal women.

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

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Bazedoxifene; Estrogens, Conjugated (USP)

Criteria

Inclusion Criteria:

• For inclusion into the study, women must be healthy and postmenopausal (either naturally or surgically) between the ages of 35 and 70, inclusive.

• Blood hormone levels must be consistent with a postmenopausal state (for specified subjects).

• They can either be a non-smoker or smoke less than 10 cigarettes per day, and be able to abstain from smoking during clinic confinements

Exclusion Criteria:

• A subject will be excluded from participation if they :

• Have participated in a clinical drug study within 30 days prior to study medication administration;

• Have a history of drug or alcohol abuse within 1 year or consume more than 2 standard units per day of alcohol (a standard unit equals 12 ounces of beer, 1 ½ ounces of 80-proof alcohol or 6 ounces of wine);

• Donate any other plasma or blood during the total study.