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NCT03810664 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations
A Phase 1 study, sponsored by OPKO Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT03810664 is a Phase 1 study that has completed, run by OPKO Health. The registered enrollment target is 49 participants.
The verdict
NCT03810664, a Phase 1 study, has completed, sponsored by OPKO Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test \| Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.
Interventions
- DRUG Somatrogon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2019-01-18 |
| Est. Completion | 2019-04-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03810664
The ClinicalTrials.gov registry entry for NCT03810664 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OPKO Health, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Somatrogon is the first listed.
NCT03810664 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03810664 about?
NCT03810664 is a clinical study titled "A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations". This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test \| Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.
What is the current status of trial NCT03810664?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2019-01-18. Estimated completion is 2019-04-19.
What interventions are being tested in trial NCT03810664?
The interventions under investigation include: Somatrogon (DRUG).
Who is sponsoring clinical trial NCT03810664?
This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.
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