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

Phase 1 Completed 93 enrolled Novo Nordisk A/S

RandomizedCrossoverSingle-blindTreatment

Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to compare repaglinide and metformin as co-administered tablets and as a combination tablet.

Timeline

Start: 2006-06
Primary completion: 2006-08
Completion: 2006-08

Outcome

Met primary endpoint

paper the limits of the 90% confidence interval of the mean treatment ratio for all pharmacokinetic parameters were contained within the pre-specified interval required for bioequivalence PMID 18666804 ↗

Publications

Results Hoelscher D, Chu PL, Lyness W. Fixed-dose combination tablet of repaglinide and metformin is bioequivalent to concomitantly administered individual tablets of repaglinide and metformin : randomized, single-blind, three-period crossover study in healthy subjects. Clin Drug Investig. 2008;28(9):573-82. doi: 10.2165/00044011-200828090-00004.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	500 mg	—
Subject	Repaglinide	Small molecule	1 mg	—
Subject	Repaglinide	Small molecule	2 mg	—