drugset / Trial / NCT00959101

Comparison of Repaglinide and Metformin Combination Tablet Versus Repaglinide and Metformin as Separate Tablets in Healthy Volunteers

NCT00959101

Phase 1 Completed 42 enrolled Novo Nordisk A/S
RandomizedCrossoverSingle-blindTreatment

Summary

This trial is conducted in Asia. The aim of this clinical trial is to investigate the bioequivalence of repaglinide and metformin combination tablet versus repaglinide and metformin as coadministered tablets after meal. The trial is designed as a three-period, six-sequence, single-dose, crossover pharmacokinetic trial where the trial participant is randomised to one of six possible treatment periods (Williams design). The trial participant will receive one single dose of each trial product in varying order.

Timeline

Start
2009-08
Primary completion
2009-10
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 500 mg
Subject Repaglinide Small molecule 1 mg
Subject Repaglinide Small molecule 2 mg

Indications