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Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism; Hypogonadism, Male

Intervention: Nanomilled testosterone (Drug); commercially available dutasteride (Drug); Nanomilled dutasteride (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: lab tests for relative bioavailability of testosterone and dutasteride,

Secondary outcome:

safety lab tests of various testosterone/dutasteride formulations,

lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Male.


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.

Locations and Contacts

GSK Investigational Site, Tacoma, Washington 98418, United States
Additional Information

Starting date: October 2006
Last updated: May 31, 2012

Page last updated: August 23, 2015

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