Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Healthy Volunteers
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
1 other identifier
interventional
62
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes
Started Jun 2006
Shorter than P25 for phase_1 diabetes
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 8, 2011
CompletedFirst Posted
Study publicly available on registry
December 9, 2011
CompletedFebruary 10, 2017
February 1, 2017
1 month
December 8, 2011
February 9, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Fasting repaglinide and metformin Area under the Curve (AUC) following NN4440 administration
Fasting repaglinide and metformin Area under the Curve (AUC) following individual administration
Fasting repaglinide and metformin Cmax (maximum drug concentration) following NN4440 administration
Fasting repaglinide and metformin Cmax (maximum drug concentration) following individual administration
Secondary Outcomes (4)
Repaglinide and metformin tmax (time to maximum) following individual administration fasting state
Repaglinide and metformin tmax (time to maximum) following NN4440 administration fasting state
Physical examinations
Vital signs
Study Arms (4)
Treatment period 1
EXPERIMENTALTreatment period 2
EXPERIMENTALTreatment period 3
EXPERIMENTALTreatment period 4
ACTIVE COMPARATORInterventions
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
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
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (2)
Novo Nordisk Investigational Site
Miami, Florida, 33169, United States
Novo Nordisk Investigational Site
Tacoma, Washington, 98418, United States
Related Publications (1)
Reilley S, Chang C-T, Lyness W. Single-Dose Pharmacokinetics of a Repaglinide/Metformin Fixed-Dose Combination Tablet in Fasted and Fed Conditions. Diabetes 2008; 57 (Suppl 1): 2449 in 01-D
RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2011
First Posted
December 9, 2011
Study Start
June 1, 2006
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
February 10, 2017
Record last verified: 2017-02