DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 hours

Cmax, maximum insulin aspart concentration

Secondary outcome:

tmax, time to maximum insulin aspart concentration

Area 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017