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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Page 1 of 1 (1 locations)

1

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan