Clinical Trial: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open Label Study to Evaluate the Impact of Novel Fixed-dose Testosterone/Dutasteride Combinations on the Relative Bioavailability of the Individual Dutasteride and Testosterone Components
Brief Summary: The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone administered with and without dutasteride
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome: lab tests for relative bioavailability of testosterone and dutasteride, [ Time Frame: days 1, 2, 3, 19, 20, 21 & 26-31 ]
Original Primary Outcome: lab tests for relative bioavailability of testosterone and dutasteride, days 1, 2, 3, 19, 20, 21 & 26-31
Current Secondary Outcome:
- safety lab tests of various testosterone/dutasteride formulations, [ Time Frame: days 1, 2, 3, 19, 20, 21 & 26-31. ]
- lab tests for additional pharmacokinetic parameters for testosterone & dutasteride, [ Time Frame: days 1, 2, 3, 19, 20, 21 & 26-31. ]
Original Secondary Outcome:
- safety lab tests of various testosterone/dutasteride formulations, days 1, 2, 3, 19, 20, 21 & 26-31.
- lab tests for additional pharmacokinetic parameters for testosterone & dutasteride, days 1, 2, 3, 19, 20, 21 & 26-31.
Information By: GlaxoSmithKline
Dates:
Date Received: November 14, 2006
Date Started: October 2006
Date Completion:
Last Updated: May 31, 2012
Last Verified: February 2011
