Status:
COMPLETED
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 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 50 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
- The receipt of any investigational drug within the last 3 months prior to this trial.
- 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
- 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
Key Trial Info
Start Date :
November 11 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2003
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01527643
Start Date
November 11 2003
End Date
December 17 2003
Last Update
February 24 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novo Nordisk Investigational Site
Neuss, Germany, 41460