Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

August 31, 2006

Study Completion Date

August 31, 2006

Conditions
DiabetesDiabetes Mellitus, Type 2
Interventions
DRUG

repaglinide

Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods

DRUG

metformin

Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods

DRUG

repaglinide and metformin combination tablet

Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods

Trial Locations (1)

78744

Novo Nordisk Investigational Site, Austin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY