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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01527552
First received: February 2, 2012
Last updated: February 22, 2017
Last verified: February 2017

February 2, 2012
February 22, 2017
November 5, 2002
December 18, 2002   (Final data collection date for primary outcome measure)
  • Area under the insulin aspart curve in the interval from 0-16 hours
  • Cmax, maximum insulin aspart concentration
Same as current
Complete list of historical versions of study NCT01527552 on ClinicalTrials.gov Archive Site
  • tmax, the time to maximum insulin aspart concentration
  • Area under the insulin aspart curve
  • Mean residence time (MRT)
  • The area under the glucose infusion rate curve
  • GIRmax, maximum glucose infusion rate value
  • tGIRmax, time to maximum glucose infusion rate value
  • Adverse events
Same as current
Not Provided
Not Provided
 
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects
A Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects
This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 in healthy male subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
  • Diabetes
  • Healthy
Drug: biphasic insulin aspart 50
A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days
  • Experimental: Formulation A
    Intervention: Drug: biphasic insulin aspart 50
  • Experimental: Formulation B
    Intervention: Drug: biphasic insulin aspart 50
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 18, 2002
December 18, 2002   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Considered generally healthy upon completion of medical history and physical examination, as judged by the investigator
  • Body Mass Index (BMI) between 19-29 kg/m^2 (both inclusive)
  • Minimum body weight of 65 kg
  • Fasting blood glucose between 3.8-6.0 mmol/L
  • Glycohemoglobin (HbA1c) below 6.4 %
  • Non-smokers

Exclusion Criteria:

  • Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
  • A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject
  • History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)
  • Hepatitis B or C
  • Subjects with a first-degree relative with diabetes mellitus
  • Known or suspected allergy to trial product or related products
  • Smoking during the past three months
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
 
NCT01527552
BIASP-1488
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP