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Pharmacokinetic Profile of OROS Hydromorphone in Healthy Taiwanese Participants With Different Genotypes for the UGT2B7 Gene

NCT01487564 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2013-03-04

No results posted yet for this study

Summary

The purpose of this study is to investigate the pharmacokinetics of OROS hydromorphone in healthy adult Taiwanese participants after the oral administration of a single 16 mg dose.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Hydromorphone 16 mg

type= exact number, unit= mg, number= 16, format= tablet, route= oral use. One tablet of hydromorphone 16 mg.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Development, L.L.C. Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Taiwan

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 NCT01487564 on ClinicalTrials.gov