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 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 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
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