Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Subjects
Status and phase
Completed
Phase 1
Conditions
Healthy
Diabetes
Treatments
Drug: biphasic insulin aspart 50
Details and patient eligibility
About
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.
Enrollment
30 patients
Sex
Male
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- 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 criteria
- 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
30 participants in 2 patient groups
Formulation A
Experimental group
Treatment:
Drug: biphasic insulin aspart 50
Formulation B
Experimental group
Treatment:
Drug: biphasic insulin aspart 50
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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