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Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
This study has been completed.
Study NCT00400335   Information provided by GlaxoSmithKline
First Received: November 14, 2006   Last Updated: October 9, 2008   History of Changes

November 14, 2006
October 9, 2008
October 2006
 
lab tests for relative bioavailability of testosterone and dutasteride, [ Time Frame: days 1, 2, 3, 19, 20, 21 & 26-31 ]
lab tests for relative bioavailability of testosterone and dutasteride, days 1, 2, 3, 19, 20, 21 & 26-31
Complete list of historical versions of study NCT00400335 on ClinicalTrials.gov Archive Site
  • 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. ]
  • 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.
 
Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
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

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

 
Phase I
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics/Dynamics Study
Hypogonadism
  • Drug: Nanomilled testosterone
  • Drug: commercially available dutasteride
  • Drug: Nanomilled dutasteride
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
60
 
 

Inclusion criteria:

  • Are healthy.
  • Have a BMI within range of 19-32 kg/m2.
  • Have not taken dutasteride for one year, or finasteride for the past 3 months.
  • Have a screening PSA < 2.0ng/mL.

Exclusion criteria:

  • Have had or have breast or prostate cancer, sleep apnea, psychiatric illness, or any other clinically significant current condition.
  • Have a trigliceride level =500mg/dL.
  • Have abnormal thyroid or hormone levels.
  • Would donate more than 500 ML of blood over a 2 month period.
  • Physician does not think it is a good idea for you to participate in the trial.
  • Are unwilling to abstain from alcohol during the study.
  • Have a positive urine drug screen test.
  • Plan to change your smoking habits during the course of the trial.
  • Have Hepatitis C, Hepatitis B, or HIV.
  • Have a lab or ECG abnormality.
  • Have high or low blood pressure.
  • Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00400335
Study Director, GSK
TDC106222
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, M.D., Ph.D., FACP GlaxoSmithKline
GlaxoSmithKline
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP