Status:
COMPLETED
Comparison of Repaglinide and Metformin Combination Tablet Versus Repaglinide and Metformin as Separate Tablets in Healthy Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00959101
Start Date
August 1 2009
End Date
October 1 2009
Last Update
March 24 2015
Active Locations (1)
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1
Beijing, Beijing Municipality, China, 100032