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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 is a Phase 1 study that has completed, run by Lumosa Therapeutics Co.. The registered enrollment target is 24 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04256434
The ClinicalTrials.gov registry entry for NCT04256434 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lumosa Therapeutics Co., which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dinalbuphine sebacate is the first listed.
NCT04256434 reports 0 study locations.
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.
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