Trials / Completed
CompletedNCT03792477
A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-TREATMENT SINGLE-DOSE, CROSS-OVER STUDY, 2-PART DESIGN TO EVALUATE THE BIOEQUIVALENCE AND TOLERABILITY OF TESTOSTERONE CYPIONATE FOLLOWING INTRAMUSCULAR (IM) INJECTION IN HEALTHY HYPOGONADAL MALE SUBJECTS
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection relative to the currently approved marked formulation (reference). In the first part of the study (Part 1), an estimate of the exposure variability will be evaluated for both test and reference. This will help guide sample size in Part 2. Part 2 will be powered to assess the BE of both test and reference formulations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Test formulation | A single testosterone cypionate solution for injection (new formulation) 200 mg dose administered IM deep in the gluteal muscle (Test formulation). |
| BIOLOGICAL | Reference formulation | A single testosterone cypionate solution for injection (currently marketed formulation) 200 mg dose administered IM deep in the gluteal muscle (Reference formulation). |
Timeline
- Start date
- 2019-01-19
- Primary completion
- 2020-04-02
- Completion
- 2020-04-02
- First posted
- 2019-01-03
- Last updated
- 2021-04-29
- Results posted
- 2021-04-29
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03792477. Inclusion in this directory is not an endorsement.