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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: repaglinide; Drug: metformin; Drug: repaglinide and metformin combination tablet

• Registration Number: NCT01490658
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-09
• Study First Posted: 2011-12-13
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• Healthy male and female volunteers (female not pregnant, lactating or breastfeeding)
• BMI (Body Mass Index) between 19-29 kg/m^2, both inclusive
• Fasting plasma glucose from 70-115 mg/dl
• Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data

Exclusion Criteria

• Any clinically significant disease history, in the opinion of the Investigator, of systemic or organ disease
• Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening
• Positive results on screening for Hepatitis B surface antigen, Hepatitis C antibody and HIV (human immunodeficiency virus) antibody
• Positive results on the drug abuse/alcohol screen
• Any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens, other than contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product dose administration) and for the duration of the study
• Subject is currently a smoker (more than one cigarette per day or equivalent)
• Use of grapefruit or grapefruit juice within 7 days of trial product dose administration
• Blood donation, surgery or trauma with significant blood loss (500 mL) within the last 2 months prior to dosing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment period 2	repaglinide and metformin combination tablet	-
Treatment period 3	repaglinide and metformin combination tablet	-
Treatment period 1	repaglinide and metformin combination tablet	-
Treatment period 1	metformin	-
Treatment period 2	metformin	-
Treatment period 1	repaglinide	-
Treatment period 2	repaglinide	-
Treatment period 3	repaglinide	-
Treatment period 3	metformin	-

Primary Outcome Measures

Name	Time	Method
Repaglinide and metformin AUC (Area under the Curve) fed state concomitant tablet administration
Repaglinide and metformin AUC (Area under the Curve) NN4440 (2/500) combination tablet
Repaglinide and metformin Cmax (maximum plasma concentration) fed state concomitant tablet administration
NN4440 (2/500) Cmax (maximum plasma concentration) combination tablet

Secondary Outcome Measures

Name	Time	Method
Repaglinide Cmax after NN4440 ((1/500) during fed state
Repaglinide AUC after NN4440 (1/500) during fed state
Change in physical examinations from screening
Vital signs

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Austin, Texas, United States