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drugset / Trial / NCT04256434

A Bioavailability Study of NALDEBAIN ER Injection and Nalbuphine Injection in Healthy Volunteers.

NCT04256434 ↗

Phase 1 Completed 24 enrolled Lumosa Therapeutics Co., Ltd.
RandomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2020-01-31
Primary completion
2020-05-29
Completion
2020-05-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Dinalbuphine sebacate Small molecule 150 mg Intramuscular
Comparator Nalbuphine Small molecule 20 mg Intramuscular

Indications

No indication recorded.