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

NCT ID: NCT00959101

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2009-10-31

Brief 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.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A

Group Type: EXPERIMENTAL

repaglinide and metformin combination tablet

Intervention Type: DRUG

Combination tablet of repaglinide (1.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast

B

Group Type: EXPERIMENTAL

repaglinide and metformin combination tablet

Intervention Type: DRUG

Combination tablet of repaglinide (2.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast

C

Group Type: ACTIVE_COMPARATOR

repaglinide

Intervention Type: DRUG

Co-administration of metformin 500 mg tablet and repaglinide 2 mg tablet given just prior to a standard normal breakfast

metformin

Intervention Type: DRUG

Concomitant administration: Metformin 500 mg tablet and Repaglinide 2 mg tablet

Interventions

repaglinide and metformin combination tablet

Combination tablet of repaglinide (1.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast

Intervention Type: DRUG

repaglinide and metformin combination tablet

Combination tablet of repaglinide (2.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast

Intervention Type: DRUG

repaglinide

Co-administration of metformin 500 mg tablet and repaglinide 2 mg tablet given just prior to a standard normal breakfast

Intervention Type: DRUG

metformin

Concomitant administration: Metformin 500 mg tablet and Repaglinide 2 mg tablet

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Beijing, Beijing Municipality, China

Countries

China

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

NN4440-1963

Identifier Type: -

Identifier Source: org_study_id