Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy Volunteers

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Metformin; Repaglinide

Criteria

Inclusion Criteria:

• 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 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

• 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