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

A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Testing the Bioequivalence of Two Formulations of NN-X14Mix50 in Healthy Japanese Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01620437

Enrollment

Registered

2012-06-15

Start date

2003-11-29

Completion date

2003-12-30

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

Brief summary

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.

Interventions

DRUGbiphasic insulin aspart 50

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Area under the insulin aspart curve in the interval from 0-16 hours	—
Cmax, maximum insulin aspart concentration	—

Secondary

Measure	Time frame
Mean residence time (MRT)	—
tmax, time to maximum insulin aspart concentration	—
Adverse events	—
t½, terminal half-life	—
Area under the insulin aspart curve	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026