Status:
COMPLETED
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 20 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2003
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01527565
Start Date
January 20 2003
End Date
February 26 2003
Last Update
February 24 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Bloemfontein, South Africa, 9324