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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: Completed Phase 1 study, sponsored by OPKO Health.
NCT03810664 is a Phase 1 study that has completed, run by OPKO Health. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT03810664 record still lists
NCT03810664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 1 intervention - of which Somatrogon is the first listed.
NCT03810664 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03810664's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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