Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Subjects
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Healthy
Intervention: biphasic insulin aspart 70 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s): Hans Henrik Friberg, Study Director, Affiliation: Novo Nordisk A/S
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.
Clinical Details
Official title: Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Formulation 2 and Formulation 4 of Biphasic Insulin Aspart 70 in Healthy Male Subjects
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Area under the insulin aspart curve in the interval from 0-16 hoursCmax, maximum insulin aspart concentration
Secondary outcome: tmax, time to maximum insulin aspart concentrationArea under the insulin aspart curve Mean residence time (MRT) t½, terminal half-life Incidence of hypoglycaemic events
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
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
Locations and Contacts
Neuss 41460, Germany
Additional Information
Clinical Trials at Novo Nordisk
Starting date: December 2003
Last updated: August 29, 2012
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