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A Pivotal Study to Evaluate the Bio-equivalence of the Tapentadol Extended-Release (ER) Tamper-resistant Formulation (TRF) Tablet to the Current Tapentadol ER Prolonged-release 2 (PR2) Tablet

NCT01900587 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2013-11-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate bio-equivalence of tapentadol extended-release (ER) tamper-resistant formulation (TRF) tablet, to the current tapentadol ER, prolonged-release formulation 2 (PR2) tablet, in healthy participants.

Conditions

  • Healthy

Interventions

DRUG

Tapentadol ER Tamper-resistant Formulation (TRF)

Single dose of tapentadol ER 50 milligram (mg), will be administered under fasted condition.

DRUG

Tapentadol ER Prolonged-Release 2 (PR2)

Single dose of tapentadol ER 50 milligram (mg), prolonged release tablet will be administered under fasted condition.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical R&D, L.L.C Clinical Trial · Johnson & Johnson Pharmaceutical R&D, L.L.C

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-08-31
Completion
2010-08-31

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 NCT01900587 on ClinicalTrials.gov