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NCT03792477 · ClinicalTrials.gov registry record · Phase 1
A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT03792477 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 74 participants.
The verdict
NCT03792477, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Test formulation
- BIOLOGICAL Reference formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2019-01-19 |
| Est. Completion | 2020-04-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03792477
The ClinicalTrials.gov registry entry for NCT03792477 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Test formulation is the first listed.
NCT03792477 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03792477 about?
NCT03792477 is a clinical study titled "A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males". 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 ...
What is the current status of trial NCT03792477?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2019-01-19. Estimated completion is 2020-04-02.
What interventions are being tested in trial NCT03792477?
The interventions under investigation include: Test formulation (BIOLOGICAL), Reference formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT03792477?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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