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Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Japanese 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 50 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Hiromasa Ono, Study Director, Affiliation: Novo Nordisk Pharma Ltd.

Summary

This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.

Clinical Details

Official title: A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Testing the Bioequivalence of Two Formulations of NN-X14Mix50 in Healthy Japanese 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

Adverse events

Eligibility

Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- BMI (body mass index) between 19-29 kg/m^2 (both inclusive)

- Fasting blood glucose between 3. 8-6. 0 mmol/L (both inclusive)

- Non-smokers

Exclusion Criteria:

- Subjects with a first-degree relative with diabetes mellitus

- Subjects smoke 5 cigarettes or more per day

Locations and Contacts

Tokyo 103, Japan
Additional Information

Clinical Trials at Novo Nordisk

Starting date: November 2003
Last updated: June 13, 2012

Page last updated: August 23, 2015

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