MedTrace Logo

A Bioavailability Study of Sebacoyl Dinalbuphine Ester IM Injection in Healthy Volunteers

NCT02446301 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-05-19

No results posted yet for this study

Summary

This study is to evaluate the relative bioavailability of nalbuphine after single IM injection of Sebacoyl Dinalbuphine Ester (SDE) injection and Bain®, Nalbuphine HCl IM injection in healthy volunteers.

Conditions

  • Pain
  • Analgesia Disorder

Interventions

DRUG

Bain®

Nalbuphine HCl 20mg, IM injection

DRUG

SDE

Sebacoyl Dinalbuphine Ester 150mg/2ml, IM injection

Sponsors & Collaborators

  • Lumosa Therapeutics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

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 NCT02446301 on ClinicalTrials.gov