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A Study to Compare the Dose-proportionality of Tapentadol (CG5503) in Healthy Japanese and Korean Male Volunteers

NCT01309425 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2014-01-31

No results posted yet for this study

Summary

The purpose of this study is to evaluate the dose-proportionality of the pharmacokinetics of tapentadol (CG5503) in healthy Japanese and Korean adult male participants.

Conditions

  • Healthy Volunteer

Interventions

DRUG

tapentadol (CG5503) ER two 100-mg TRF

200mg TRF single oral dose

DRUG

tapentadol (CG5503) ER 50-mg TRF

50mg TRF single oral dose

DRUG

tapentadol (CG5503) ER 25-mg TRF

25mg TRF single oral dose

DRUG

tapentadol (CG5503) ER 100-mg TRF

100mg TRF single oral dose

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Completion
2011-05-31

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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 NCT01309425 on ClinicalTrials.gov