Skip to main content
OpenTrials
Completed

NCT Number: NCT01527630

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator.
  • Body Mass Index (BMI) between 19-29 kg/m^2 (inclusive)
  • Fasting plasma glucose between 3.8-6.0 mmol/L (both inclusive)

Exclusion criteria

  • Clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator or Sub-Investigator
  • Any serious systemic infectious disease that had occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator
  • Any inter-current illness that might affect blood glucose, as judged by the Investigator or Sub-Investigator
  • Hepatitis B or C, or HIV (human immunodeficiency virus) positive
  • Subjects with a first degree relative with diabetes mellitus
  • History of or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder
  • Subjects who consumed more than 28 units of alcohol per week or who had a significant history of alcoholism or drug/chemical abuse
  • Subjects who smoked more than 5 cigarettes per day
  • Subjects who had taken part in strenuous exercise within 7 days prior to the screening

Treatment and study plan

biphasic insulin aspart 50

Drug

A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-21days

Primary outcomes

  1. Area under the insulin aspart concentration-time curve in the interval from 0 to 16 hours

  2. Cmax, maximum insulin aspart concentration

Secondary outcomes

  1. Area under the insulin aspart concentration-time curve

  2. Tmax, time to maximum insulin aspart concentration

  3. MRT, mean residence time

  4. t½, terminal half-life

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Feb 7, 2012
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.