NCT01778075

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

A Single Dose, Open-Label, Randomized, Two-Way Crossover Pivotal Study to Assess the Bioequivalence of a New ULTRACET ER Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2013-01-29
• Last updated: 2014-02-10

Locations

1 site across 1 country: South Korea