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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: repaglinide and metformin combination tablet; Drug: metformin; Drug: repaglinide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01490658

NN4440-1753

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

93 participants in 3 patient groups

Treatment period 1

Experimental group

Treatment:

Drug: repaglinide

Drug: metformin

Drug: repaglinide and metformin combination tablet

Treatment period 2

Experimental group

Treatment:

Drug: repaglinide

Drug: metformin

Drug: repaglinide and metformin combination tablet

Treatment period 3

Active Comparator group

Treatment:

Drug: repaglinide

Drug: metformin

Drug: repaglinide and metformin combination tablet