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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00959101
First received: August 13, 2009
Last updated: June 28, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Diabetes
Healthy
Drug: repaglinide and metformin combination tablet
Drug: repaglinide
Drug: metformin
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • AUC0-t and Cmax (after repaglinide 2.0 mg and metformin 500 mg as co-administered tablets and combination tablet dosing under fed state) [ Time Frame: 24hr profile after single dose of trial drug in each treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Repaglinide AUC(0-24 & 0-∞) and Cmax after combination tablet (repaglinide 1.0 mg/metformin 500 mg) during fed state [ Time Frame: 24hr profile after single dose of trial drug in each treatment period ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: August 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: repaglinide and metformin combination tablet
Combination tablet of repaglinide (1.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast
Experimental: B Drug: repaglinide and metformin combination tablet
Combination tablet of repaglinide (2.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast
Active Comparator: C Drug: repaglinide
Co-administration of metformin 500 mg tablet and repaglinide 2 mg tablet given just prior to a standard normal breakfast
Drug: metformin
Concomitant administration: Metformin 500 mg tablet and Repaglinide 2 mg tablet

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959101

Locations
China, Beijing
Beijing, Beijing, China, 100032
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Xu Hongfei, Master Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00959101     History of Changes
Other Study ID Numbers: NN4440-1963
Study First Received: August 13, 2009
Last Updated: June 28, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Metformin
Repaglinide
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014