Pharmacokinetic Characterization of Two Novel CG5503 Tablet Formulations in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

April 30, 2005

Primary Completion Date

June 30, 2005

Study Completion Date

June 30, 2005

Conditions
Pharmacokinetics
Interventions
DRUG

Tapentadol Test Product 1

Tapentadol tablet containing 116 mg of tapentadol hydrochloride; Tapentadol Test Product 1 contains different amounts of excipients than Tapentadol Test Product 2

DRUG

Tapentadol Test Product 2

Tapentadol tablet containing 116 mg of tapentadol hydrochloride; Tapentadol Test Product 2 contains different amounts of excipients than Tapentadol Test Product 1

DRUG

Tapentadol Prolonged-release Reference Product

Tapentadol PR tablet containing 116 mg of tapentadol hydrochloride

Trial Locations (1)

52099

Department of Clinical Pharmacology, Grünenthal GmbH, Aachen

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Grünenthal GmbH

INDUSTRY