Trials / Completed
CompletedNCT01887418
Pharmacokinetic Study of Testosterone Enanthate
3 Arm Open-label Randomized Multidose Study of Pharmacokinetics, Safety & Tolerability of Testosterone Enanthate Administered Subcutaneously Via an Auto-injector Device or Intramuscular Testosterone Enanthate in Hypogonadal Adult Males
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Antares Pharma Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.
Detailed description
Standard Pharmacokinetic (PK) analyses of data for serum testosterone were done. Cmax, Area Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the treatments and reference arm. Safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | QuickShot™ - 50 mg Treatment B | QuickShot™ for the delivery of testosterone |
| DRUG | QuickShot™ - 100 mg Treatment A | QuickShot™ for the delivery of testosterone |
| DRUG | Delatestryl 200 mg IM Treatment C | Standard of care |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2014-01-01
- Completion
- 2014-01-01
- First posted
- 2013-06-26
- Last updated
- 2018-01-11
- Results posted
- 2015-10-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01887418. Inclusion in this directory is not an endorsement.