Comparison of Repaglinide and Metformin Combination Tablet Versus Repaglinide and Metformin as Separate Tablets in Healthy Volunteers

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Treatments

Drug: metformin

Drug: repaglinide and metformin combination tablet

Drug: repaglinide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00959101

NN4440-1963

Details and patient eligibility

About

This trial is conducted in Asia. The aim of this clinical trial is to investigate the bioequivalence of repaglinide and metformin combination tablet versus repaglinide and metformin as coadministered tablets after meal.

The trial is designed as a three-period, six-sequence, single-dose, crossover pharmacokinetic trial where the trial participant is randomised to one of six possible treatment periods (Williams design). The trial participant will receive one single dose of each trial product in varying order.

Enrollment

42 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Willing to sign informed consent before initiating any trial related procedures
BMI: 19.0-25.0 kg/m2
Fasting plasma glucose: 3.9-6.1 mmol/L
Trial participant is judged to be in good health on the basis of their medical history, physical examination, ECG, 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
Any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens that cannot be stopped at least two weeks prior to start of treatment and for the duration of the trial
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 (400 mL) within the last 2 months prior to trial product dose administration
Recent history (within the last 2 years) of drug or alcohol abuse
Known or suspected allergy to trial product or any of the excipients or a history of multiple and/or severe allergies to drugs or foods or of severe anaphylactic reactions
Subject has taken an investigational drug in another clinical trial within the last 4 weeks.
Recent history (within the last 3 month) of nausea, diarrhea or gastrointestinal complaints
History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose additional risk in administering trial product to the trial participant