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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01490658
First received: December 8, 2011
Last updated: December 9, 2011
Last verified: December 2011
History of Changes
  Purpose

This trial is conducted in the United States of America (USA). The aim of this trial is to compare repaglinide and metformin as co-administered tablets and 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, Three-Period Crossover Study Examining the Single Dose Pharmacokinetics of Concomitantly Administered Repaglinide and Metformin Versus Combination Tablet Dosing (NN4440) in Fed Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Repaglinide and metformin AUC (Area under the Curve) fed state concomitant tablet administration [ Designated as safety issue: No ]
  • Repaglinide and metformin AUC (Area under the Curve) NN4440 (2/500) combination tablet [ Designated as safety issue: No ]
  • Repaglinide and metformin Cmax (maximum plasma concentration) fed state concomitant tablet administration [ Designated as safety issue: No ]
  • NN4440 (2/500) Cmax (maximum plasma concentration) combination tablet [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Repaglinide AUC after NN4440 (1/500) during fed state [ Designated as safety issue: No ]
  • Repaglinide Cmax after NN4440 ((1/500) during fed state [ Designated as safety issue: No ]
  • Change in physical examinations from screening [ Designated as safety issue: No ]
  • Vital signs [ Designated as safety issue: No ]

Enrollment: 93
Study Start Date: June 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment period 1 Drug: repaglinide
Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: metformin
Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: repaglinide and metformin combination tablet
Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Experimental: Treatment period 2 Drug: repaglinide
Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: metformin
Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: repaglinide and metformin combination tablet
Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Active Comparator: Treatment period 3 Drug: repaglinide
Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: metformin
Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: repaglinide and metformin combination tablet
Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods

  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 or herbal supplement regimens, other than contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product dose 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 dose administration
  • Blood donation, surgery or trauma with significant blood loss (500 mL) within the last 2 months prior to dosing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490658

Locations
United States, Texas
Novo Nordisk Clinical Trial Call Center
Austin, Texas, United States, 78744
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: William Lyness, Ph.D. Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01490658     History of Changes
Other Study ID Numbers: NN4440-1753
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 May 22, 2013