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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490658
• Other study ID #: NN4440-1753
• Status: Completed
• Phase: Phase 1
• First received: December 8, 2011
• Last updated: February 9, 2017
• Start date: June 2006
• Est. completion date: August 2006

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• repaglinide
Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
• metformin
Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
• repaglinide and metformin combination tablet
Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 su — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repaglinide and metformin AUC (Area under the Curve) fed state concomitant tablet administration
Primary	Repaglinide and metformin AUC (Area under the Curve) NN4440 (2/500) combination tablet
Primary	Repaglinide and metformin Cmax (maximum plasma concentration) fed state concomitant tablet administration
Primary	NN4440 (2/500) Cmax (maximum plasma concentration) combination tablet
Secondary	Repaglinide AUC after NN4440 (1/500) during fed state
Secondary	Repaglinide Cmax after NN4440 ((1/500) during fed state
Secondary	Change in physical examinations from screening
Secondary	Vital signs

External Links

•   Clinical Trials at Novo Nordisk