Status:
COMPLETED
Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in 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 administered as an individual tablets with repaglinide and metformin admini...
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, 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01489644
Start Date
June 1 2006
End Date
July 1 2006
Last Update
February 10 2017
Active Locations (2)
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1
Novo Nordisk Investigational Site
Miami, Florida, United States, 33169
2
Novo Nordisk Investigational Site
Tacoma, Washington, United States, 98418