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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489644
• Other study ID #: NN4440-1779
• Status: Completed
• Phase: Phase 1
• First received: December 8, 2011
• Last updated: February 9, 2017
• Start date: June 2006
• Est. completion date: July 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 administered as an individual tablets with repaglinide and metformin administered as a combination tablet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2006
• Est. primary completion date: July 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, 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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• repaglinide
Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order
• metformin
Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order
• repaglinide and metformin combination tablet
Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Miami	Florida
United States	Novo Nordisk Investigational Site	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

Reilley S, Chang C-T, Lyness W. Single-Dose Pharmacokinetics of a Repaglinide/Metformin Fixed-Dose Combination Tablet in Fasted and Fed Conditions. Diabetes 2008; 57 (Suppl 1): 2449 in 01-D

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting repaglinide and metformin Area under the Curve (AUC) following NN4440 administration
Primary	Fasting repaglinide and metformin Area under the Curve (AUC) following individual administration
Primary	Fasting repaglinide and metformin Cmax (maximum drug concentration) following NN4440 administration
Primary	Fasting repaglinide and metformin Cmax (maximum drug concentration) following individual administration
Secondary	Repaglinide and metformin tmax (time to maximum) following individual administration fasting state
Secondary	Repaglinide and metformin tmax (time to maximum) following NN4440 administration fasting state
Secondary	Physical examinations
Secondary	Vital signs

External Links

•   Clinical Trials at Novo Nordisk