Beijing, Beijing Municipality, 100032, China
NCT Number: NCT00959101
Comparison of Repaglinide and Metformin Combination Tablet Versus Repaglinide and Metformin as Separate Tablets in Healthy Volunteers
This trial is conducted in Asia. The aim of this clinical trial is to investigate the bioequivalence of repaglinide and metformin combination tablet versus repaglinide and metformin as coadministered tablets after meal.
The trial is designed as a three-period, six-sequence, single-dose, crossover pharmacokinetic trial where the trial participant is randomised to one of six possible treatment periods (Williams design). The trial participant will receive one single dose of each trial product in varying order.
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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
repaglinide and metformin combination tablet
DrugCombination tablet of repaglinide (1.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast
repaglinide
DrugCo-administration of metformin 500 mg tablet and repaglinide 2 mg tablet given just prior to a standard normal breakfast
metformin
DrugConcomitant administration: Metformin 500 mg tablet and Repaglinide 2 mg tablet
Primary outcomes
-
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
Secondary outcomes
-
Repaglinide AUC(0-24 & 0-∞) 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
Sponsors and collaborators
Lead sponsor
Novo Nordisk A/S
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2009
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Aug 14, 2009
- Registry last updated
- Mar 24, 2015
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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