Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GRT9906 Prolonged Release Tablets After Dose Escalation in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

September 15, 2004

Primary Completion Date

March 23, 2005

Study Completion Date

March 23, 2005

Conditions
Pharmacokinetics
Interventions
DRUG

GRT9906 PR tablet

40 mg GRT9906 PR tablet oral (minimal release of 80 percent after 480 minutes)

DRUG

Placebo

Placebo tablet matching 40 mg GRT9906 PR tablet

Trial Locations (1)

41460

FOCUS Clinical Drug Development GmbH, Neuss

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Grünenthal GmbH

INDUSTRY