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

PHASE1CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

February 28, 2013

Study Completion Date

February 28, 2013

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.

Trial Locations (1)

Unknown

Seoul

All Listed Sponsors
lead

Janssen Korea, Ltd., Korea

INDUSTRY

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 | Biotech Hunter | Biotech Hunter