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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01489644
First received: December 8, 2011
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: repaglinide
Drug: metformin
Drug: repaglinide and metformin combination tablet
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 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Fasting repaglinide and metformin Area under the Curve (AUC) following NN4440 administration [ Designated as safety issue: No ]
  • Fasting repaglinide and metformin Area under the Curve (AUC) following individual administration [ Designated as safety issue: No ]
  • Fasting repaglinide and metformin Cmax (maximum drug concentration) following NN4440 administration [ Designated as safety issue: No ]
  • Fasting repaglinide and metformin Cmax (maximum drug concentration) following individual administration [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Repaglinide and metformin tmax (time to maximum) following individual administration fasting state [ Designated as safety issue: No ]
  • Repaglinide and metformin tmax (time to maximum) following NN4440 administration fasting state [ Designated as safety issue: No ]
  • Physical examinations [ Designated as safety issue: No ]
  • Vital signs [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: June 2006
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment period 1 Drug: repaglinide
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
Drug: metformin
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
Drug: repaglinide and metformin combination tablet
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
Experimental: Treatment period 2 Drug: repaglinide
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
Drug: metformin
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
Drug: repaglinide and metformin combination tablet
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
Experimental: Treatment period 3 Drug: repaglinide
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
Drug: metformin
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
Drug: repaglinide and metformin combination tablet
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
Active Comparator: Treatment period 4 Drug: repaglinide
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
Drug: metformin
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
Drug: repaglinide and metformin combination tablet
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01489644

Locations
United States, Washington
Novo Nordisk Clinical Trial Call Center
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: William Lyness, Ph.D. Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01489644     History of Changes
Other Study ID Numbers: NN4440-1779
Study First Received: December 8, 2011
Last Updated: December 9, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Repaglinide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014