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

Phase 1

Completed

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

• Registration Number: NCT01489644
• 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 administered as an individual tablets with repaglinide and metformin administered as a combination tablet.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-08
• Study First Posted: 2011-12-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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, health food or dietary supplement regimens, with the exception of contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product 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 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 4	repaglinide and metformin combination tablet	-
Treatment period 4	metformin	-
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	repaglinide	-
Treatment period 1	metformin	-
Treatment period 4	repaglinide	-
Treatment period 2	repaglinide	-
Treatment period 2	metformin	-
Treatment period 3	metformin	-
Treatment period 3	repaglinide	-

Primary Outcome Measures

Name	Time	Method
Fasting repaglinide and metformin Area under the Curve (AUC) following NN4440 administration
Fasting repaglinide and metformin Cmax (maximum drug concentration) following NN4440 administration
Fasting repaglinide and metformin Area under the Curve (AUC) following individual administration
Fasting repaglinide and metformin Cmax (maximum drug concentration) following individual administration

Secondary Outcome Measures

Name	Time	Method
Repaglinide and metformin tmax (time to maximum) following individual administration fasting state
Repaglinide and metformin tmax (time to maximum) following NN4440 administration fasting state
Physical examinations
Vital signs

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Tacoma, Washington, United States