Status:
COMPLETED
Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect
Lead Sponsor:
Pfizer
Conditions:
Therapeutic Equivalency
Food
Eligibility:
MALE
20-55 years
Phase:
PHASE1
Brief Summary
Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial formulation in both under fasted and fed condition, and bioequivalence between formulation E(1) used in Japanese p...
Eligibility Criteria
Inclusion
- Japanese healthy male subject
Exclusion
- Evidence or history of clinically significant findings at screening
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00807118
Start Date
October 1 2008
End Date
December 1 2008
Last Update
March 24 2010
Active Locations (1)
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1
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan