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

NCT04256434 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-11-19

No results posted yet for this 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.

Conditions

  • Health

Interventions

DRUG

Dinalbuphine sebacate

150 mg Dinalbuphine sebacate

DRUG

Nalbuphine HCl

20 mg Nalbuphine

Sponsors & Collaborators

  • Lumosa Therapeutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • David Nguyen, MD · WCCT Global

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2020-05-29
Completion
2020-05-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04256434 on ClinicalTrials.gov