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Formulations A and B of Premarin/MPA/ and PREMPRO

Phase 1

Postmenopausal Osteoporosis | Small molecule | Endocrine |Pfizer, Inc.|Last Updated: Jun 11, 2007

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

Formulations A and B of Premarin/MPA/ and PREMPRO · 1 trial · 2 indications

Phase 1 1
NCT00381251Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.Postmenopausal Osteoporosis
COMPLETED- Analytics
PHASE1COMPLETED
Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.
Postmenopausal Osteoporosis
NCT00381251-
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Study Endpoints

Primary Endpoints

Pharmacokinetic blood samples for unconjugated and total (unconjugated plus conjugated) estrogens and MPA will be obtained. The following pharmacokinetic parameters will be determined: Cmax, Tmax, t½, AUC0-T, AUC0-¥.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposePREVENTION

Interventions

NameTypeDescription
Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mgDRUG -
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Eligibility Criteria

Age Range35 Years to 70 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy, postmenopausal women ages 35 to 70 years, inclusive. * Naturally postmenopausal women must not have had a menstrual period for at least six months, but less than 12 months, as confirmed by a blood test; or for at least 12 months with no blood hormone test confirmation...

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