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Completed

NCT Number: NCT01489644

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

repaglinide

Drug

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

Drug

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

Drug

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

Primary outcomes

  1. Fasting repaglinide and metformin Area under the Curve (AUC) following NN4440 administration

  2. Fasting repaglinide and metformin Area under the Curve (AUC) following individual administration

  3. Fasting repaglinide and metformin Cmax (maximum drug concentration) following NN4440 administration

  4. Fasting repaglinide and metformin Cmax (maximum drug concentration) following individual administration

Secondary outcomes

  1. Repaglinide and metformin tmax (time to maximum) following individual administration fasting state

  2. Repaglinide and metformin tmax (time to maximum) following NN4440 administration fasting state

  3. Physical examinations

  4. Vital signs

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Dec 9, 2011
Registry last updated
Feb 10, 2017

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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