Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Subjects

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

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:

• 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