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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01489644

NN4440-1779

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 administered as an individual tablets with repaglinide and metformin administered as a combination tablet.

Enrollment: 62 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, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

62 participants in 4 patient groups

Treatment period 1

Experimental group

Treatment:

Drug: repaglinide and metformin combination tablet

Drug: repaglinide

Drug: metformin

Treatment period 2

Experimental group

Treatment:

Drug: repaglinide and metformin combination tablet

Drug: repaglinide

Drug: metformin

Treatment period 3

Experimental group

Treatment:

Drug: repaglinide and metformin combination tablet

Drug: repaglinide

Drug: metformin

Treatment period 4

Active Comparator group

Treatment:

Drug: repaglinide and metformin combination tablet

Drug: repaglinide

Drug: metformin