Status:
COMPLETED
Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT01490658
Start Date
June 1 2006
End Date
August 1 2006
Last Update
February 10 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Austin, Texas, United States, 78744