Title
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
Phase
Phase 1/Phase 2Lead Sponsor
Antares Pharma Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
HypogonadismIntervention/Treatment
urea testosterone ...Study Participants
39Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.
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.
QuickShot™ for the delivery of testosterone
QuickShot™ for the delivery of testosterone
Standard of care
QuickShot™Testosterone - Auto-injector device for SC use
QuickShot™Testosterone- Auto-injector device for SC use
Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference
Inclusion Criteria: Adult males aged 18 to 75 with a documented diagnosis of hypogonadism Exclusion Criteria: Normal testosterone levels Subjects with any clinically significant medical condition which, in the opinion of the Investigator, would make the subject an unsuitable candidate for enrollment in the study
| Event Type | Organ System | Event Term | QuickShot™ - 100 mg Treatment A | QuickShot™ - 50 mg Treatment B | Delatestryl 200 mg IM Treatment C |
|---|
The area under the curve from time zero to last quantifiable concentration [AUC (0-t)] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
The maximum observed plasma concentration [Cmax] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
The average concentration [Cavg] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
The number of TT Cavg (0-168h) values within the normal range (300-1100 ng/dL) following treatment with SC TE administered via QST or IM TE
