Effect of a Multiple-dose Oral Administration of CG5503 PR on the Electrical Activity of the Heart in 48 Healthy Men and Women

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 31, 2003

Primary Completion Date

August 31, 2003

Study Completion Date

August 31, 2003

Conditions
Prolonged QTc IntervalPharmacokinetic
Interventions
DRUG

100 mg CG5503 (tapentadol hydrochloride) PR tablet

100 mg CG5503 (tapentadol hydrochloride) PR tablet.

DRUG

Placebo matching CG5503 PR tablet

Matching placebo tablet to CG5503 PR tablet.

DRUG

Placebo matching moxifloxacin capsule

Matching placebo capsule to moxifloxacin capsule.

DRUG

400 mg Moxifloxacin tablet (overencapsulated)

Overencapsulated 400 mg Moxifloxacin tablet.

Trial Locations (1)

41460

DE001 - Contract research organisation, Neuss

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Grünenthal GmbH

INDUSTRY