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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00959101 |
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Date of registration:
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13/08/2009 |
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Primary sponsor: |
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Public title:
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Comparison of Repaglinide and Metformin Combination Tablet Versus Repaglinide and Metformin as Separate Tablets in Healthy Volunteers
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Scientific title:
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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 |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00959101 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Xu Hongfei, Master |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Diabetes
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Healthy
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Intervention(s)
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Drug: metformin
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Drug: repaglinide
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Drug: repaglinide and metformin combination tablet
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Repaglinide AUC(0-24 & 0-8) 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]
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Secondary ID(s)
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NN4440-1963
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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