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NCT04256434 · ClinicalTrials.gov registry record · Phase 1
A Bioavailability Study of NALDEBAIN ER Injection and Nalbuphine Injection in Healthy Volunteers.
A Phase 1 study, sponsored by Lumosa Therapeutics Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT04256434: Completed Phase 1 study, sponsored by Lumosa Therapeutics Co..
NCT04256434 is a Phase 1 study that has completed, run by Lumosa Therapeutics Co.. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04256434, a Phase 1 study, has completed, sponsored by Lumosa Therapeutics Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is an open-label, sequential 2 cohort, intramuscular injection study in healthy volunteers. The study will enroll approximately 24 healthy volunteers to examine the safety, pharmacokinetics, and bioavailability after intramuscular injection of NALDEBAIN ER Injection and nalbuphine injection.
Primary Outcome
To evaluate the relative bioavailability of nalbuphine after intramuscular injection of NALDEBAIN and Nalbuphine.
Interventions
- DRUG Dinalbuphine sebacate
- DRUG Nalbuphine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-01-31 |
| Est. Completion | 2020-05-29 |
| Phase | Phase 1 |
What the finished NCT04256434 record still lists
NCT04256434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Dinalbuphine sebacate is the first listed.
NCT04256434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04256434 about?
NCT04256434 is a clinical study titled "A Bioavailability Study of NALDEBAIN ER Injection and Nalbuphine Injection in Healthy Volunteers.". This is an open-label, sequential 2 cohort, intramuscular injection study in healthy volunteers. The study will enroll approximately 24 healthy volunteers to examine the safety, pharmacokinetics, and bioavailability after intramuscular injection of NALDEBAIN ER Injection and nalbuphine injection.
What is the current status of trial NCT04256434?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-01-31. Estimated completion is 2020-05-29.
What interventions are being tested in trial NCT04256434?
The interventions under investigation include: Dinalbuphine sebacate (DRUG), Nalbuphine HCl (DRUG).
Who is sponsoring clinical trial NCT04256434?
This trial is sponsored by Lumosa Therapeutics Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04256434's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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