Comparison of Repaglinide and Metformin Combination Tablet Versus Repaglinide and Metformin as Separate Tablets in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Randomised, 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 Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959101
• Other study ID #: NN4440-1963
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2009
• Last updated: March 23, 2015
• Start date: August 2009
• Est. completion date: October 2009

Study information

• Verified date: March 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Asia. The aim of this clinical trial is to investigate the bioequivalence of repaglinide and metformin combination tablet versus repaglinide and metformin as coadministered tablets after meal.

The trial is designed as a three-period, six-sequence, single-dose, crossover pharmacokinetic trial where the trial participant is randomised to one of six possible treatment periods (Williams design). The trial participant will receive one single dose of each trial product in varying order.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Willing to sign informed consent before initiating any trial related procedures

• BMI: 19.0-25.0 kg/m2

• Fasting plasma glucose: 3.9-6.1 mmol/L

• Trial participant is judged to be in good health on the basis of their medical history, physical examination, ECG, 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

• Any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens that cannot be stopped at least two weeks prior to start of treatment and for the duration of the trial

• 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 (400 mL) within the last 2 months prior to trial product dose administration

• Recent history (within the last 2 years) of drug or alcohol abuse

• Known or suspected allergy to trial product or any of the excipients or a history of multiple and/or severe allergies to drugs or foods or of severe anaphylactic reactions

• Subject has taken an investigational drug in another clinical trial within the last 4 weeks.

• Recent history (within the last 3 month) of nausea, diarrhea or gastrointestinal complaints

• History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose additional risk in administering trial product to the trial participant

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• repaglinide and metformin combination tablet
Combination tablet of repaglinide (1.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast
• repaglinide and metformin combination tablet
Combination tablet of repaglinide (2.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast
• repaglinide
Co-administration of metformin 500 mg tablet and repaglinide 2 mg tablet given just prior to a standard normal breakfast
• metformin
Concomitant administration: Metformin 500 mg tablet and Repaglinide 2 mg tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t and Cmax (after repaglinide 2.0 mg and metformin 500 mg as co-administered tablets and combination tablet dosing under fed state)		24hr profile after single dose of trial drug in each treatment period	No
Secondary	Repaglinide AUC(0-24 & 0-8) and Cmax after combination tablet (repaglinide 1.0 mg/metformin 500 mg) during fed state		24hr profile after single dose of trial drug in each treatment period	No

External Links

•   Clinical Trials at Novo Nordisk