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A Study to Assess the Bioequivalence of a New ULTRACET Extended Release (ER) Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition

NCT01778075 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2014-02-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate the bioequivalence of a newly developed ULTRACET extended-release (ER) tablet of tramadol hydrochloride and acetaminophen, to the current marketed ULTRACET ER tablet, in healthy participants under fasted condition.

Conditions

  • Healthy

Interventions

DRUG

Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER)

Single oral dose of newly developed ULTRACET ER, (Tramadol HCl/Acetaminophen 75/650 mg), administered under fasted condition.

DRUG

Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER)

Single oral dose of marketed ULTRACET ER, (Tramadol HCl/Acetaminophen 75/650 mg), administered under fasted condition.

Sponsors & Collaborators

  • Janssen Korea, Ltd., Korea

    lead INDUSTRY

Principal Investigators

  • Janssen Korea, Ltd., Korea Clinical Trial · Janssen Korea, Ltd., Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • South Korea

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 NCT01778075 on ClinicalTrials.gov