Clinical trial · Interventional
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
NCT00400335CI-TRIAL-00007043completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypogonadism | — | UNRESOLVED | — |
| Hypogonadism, Male | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| commercially available dutasteride | Drug | — | UNRESOLVED |
| Nanomilled dutasteride | Drug | — | UNRESOLVED |
| Nanomilled testosterone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- lab tests for relative bioavailability of testosterone and dutasteride,
- timeFrame
- days 1, 2, 3, 19, 20, 21 & 26-31
Secondary outcomes (2)
- measure
- safety lab tests of various testosterone/dutasteride formulations,
- timeFrame
- days 1, 2, 3, 19, 20, 21 & 26-31.
- measure
- lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,
- timeFrame
- days 1, 2, 3, 19, 20, 21 & 26-31.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.