Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male 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 Africa. 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 19-29 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
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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