Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Japanese Subjects

Phase 1CompletedNCT01620437

Novo Nordisk A/S30 enrolled

Overview

This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Healthy

Interventions

biphasic insulin aspart 50DRUG

A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-21 days will take place between dosing visits

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI (body mass index) between 19-29 kg/m\^2 (both inclusive) * Fasting blood glucose between 3.8-6.0 mmol/L (both inclusive) * Non-smokers Exclusion Criteria: * Subjects with a first-degree relative with diabetes mellitus * Subjects smoke 5 cigarettes or more per day

Locations (1)

Novo Nordisk Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

Area under the insulin aspart curve in the interval from 0-16 hours

Cmax, maximum insulin aspart concentration

Secondary Outcomes

tmax, time to maximum insulin aspart concentration

Area under the insulin aspart curve

Mean residence time (MRT)

t½, terminal half-life

Adverse events

Data from ClinicalTrials.gov

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