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NCT04256434
A Bioavailability Study of NALDEBAIN ER Injection and Nalbuphine Injection in Healthy Volunteers.
Phase 1 trial testing Dinalbuphine sebacate in Health in 24 participants. Completed in 29 May 2020.
29 May 2020
Quick facts
| Lead sponsor | Lumosa Therapeutics Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 31 January 2020 |
| Primary completion | 29 May 2020 |
| Estimated completion | 29 May 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dinalbuphine sebacate — full drug profile →
- Nalbuphine HCl
Conditions studied
- Health — all drugs for Health →
Sponsor
Lumosa Therapeutics Co., Ltd. — full company profile →
Who can join
Adults 18 to 55, any sex, with Health. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04256434
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Lumosa Therapeutics Co., Ltd. trials
Trials by the same sponsor.
- NCT05403866 — A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects · Phase 2 · completed
- NCT05198323 — A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVT · Phase 2 · recruiting
- NCT04809818 — A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects · Phase 1 · completed
- NCT04393675 — Study to Investigate the Safety of LT5001 Drug Product for Uremic Pruritus in Hemodialysis Patients · Phase 1, PHASE2 · terminated
- NCT04091945 — A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04256434 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lumosa Therapeutics Co., Ltd.
- Last refreshed: 19 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04256434.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing