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Completed

NCT Number: NCT00959101

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Beijing, Beijing Municipality, 100032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repaglinide and metformin combination tablet

Drug

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

repaglinide

Drug

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

metformin

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 14, 2009
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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