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NCT01620437 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01620437
Other study ID # BIASP-1581
Secondary ID
Status Completed
Phase Phase 1
First received June 13, 2012
Last updated February 22, 2017
Start date November 29, 2003
Est. completion date December 30, 2003

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 30, 2003
Est. primary completion date December 30, 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic 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

Locations
Country Name City State
Japan Novo Nordisk Investigational Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the insulin aspart curve in the interval from 0-16 hours
Primary Cmax, maximum insulin aspart concentration
Secondary tmax, time to maximum insulin aspart concentration
Secondary Area under the insulin aspart curve
Secondary Mean residence time (MRT)
Secondary t½, terminal half-life
Secondary Adverse events
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