Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated estrogens tablets produced using a new manufacturing process

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

Details

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

Criteria

Inclusion Criteria

• Healthy, postmenopausal women aged 35 to 70 years and weighing at least 50 kg (approx. 110 lbs).

• At least 6 months of spontaneous amenorrhea (with follicle-stimulating hormone levels of 39 mIU/mL or greater).

• Nonsmoker or smoker of fewer than 10 cigarettes per day, with ability to abstain for 5 days.

Exclusion Criteria

• Women with amenorrhea starting after 54 years of age.

• A history or active presence of clinically important medical diseases.

• Use of oral estrogen-, progestin, androgen-, or SERM-containing drug products within 30 days before receiving study drug.