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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00396799 |
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
Condition | Intervention | Phase |
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Menopause |
Drug: bazedoxifene/conjugated estrogens |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study |
Official Title: | An Open-Label, Single-Dose, Randomized-to-Sequence, 2-Period, Crossover, Pivotal Bioequivalence Study Between Bazedoxifene Acetate/Conjugated Estrogens (Premarin Current Process) and Bazedoxifene Acetate/Conjugated Estrogens (Premarin New Process) Tablets Administered to Healthy Postmenopausal Women |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2006 |
Ages Eligible for Study: | 35 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
Study ID Numbers: | 3115A1-114 |
Study First Received: | November 7, 2006 |
Last Updated: | March 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00396799 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Estrogens, Conjugated (USP) Estrogens Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Healthy Hormones Menopause |
Estrogens Estrogens, Conjugated (USP) Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |