Status:
COMPLETED
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. 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 19.0-30.0 kg/m\^2
- Glycohemoglobin (HbA1c) within laboratory normal range
- Non-smokers
Exclusion
- Clinically significant abnormal haematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
- Liver enzyme values (ALAT and ASAT) exceeding 2 times the upper reference limit according to the local laboratory
- A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the trial 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 urine drug screen and breath alcohol screen)
- HIV (human immunodeficiency virus), Hepatitis B or C positive
- Subjects with a first-degree relative with diabetes mellitus
- A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions
- Known or suspected allergy to trial product or related products
- Smoking during the past three months
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01527656
Start Date
December 1 2003
End Date
February 1 2004
Last Update
January 6 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Neuss, Germany, 41460