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A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 25-mg Tablets Relative to One 50-mg Tablet

NCT01273506 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-03-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the bioequivalence of a 50-mg tapentadol (CG5503) dose administered as two 25-mg ER, TRF tablets relative to one 50-mg ER TRF tablet in healthy Japanese male participants.

Conditions

  • Healthy Volunteer

Interventions

DRUG

tapentadol (CG5503) ER 25-mg TRF

50 mg TRF single oral dose

DRUG

tapentadol (CG5503) ER 50-mg TRF

50 mg 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
2010-12-31
Completion
2011-02-28

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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 NCT01273506 on ClinicalTrials.gov