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A Randomized, Single-Blind, Four-Period Crossover Study Examining the Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet Dosing (NN4440) in Fasting and Fed Healthy Volunteers

ClinicalTrials.gov · COMPLETED, 2006

62 participants

Abstract

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

Conditions: Diabetes, Diabetes Mellitus, Type 2.

Primary outcome: Fasting repaglinide and metformin Area under the Curve (AUC) following NN4440 administration; Fasting repaglinide and metformin Area under the Curve (AUC) following individual administration; Fasting repaglinide and metformin Cmax (maximum drug concentration) following NN4440 administration; Fasting repaglinide and metformin Cmax (maximum drug concentration) following individual administration.

Enrollment: 62 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 62 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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