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Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Japanese Subjects

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01620437
First received: June 13, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes
Healthy
 Drug: biphasic insulin aspart 50
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the insulin aspart curve in the interval from 0-16 hours [ Designated as safety issue: No ]
  • Cmax, maximum insulin aspart concentration [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tmax, time to maximum insulin aspart concentration [ Designated as safety issue: No ]
  • Area under the insulin aspart curve [ Designated as safety issue: No ]
  • Mean residence time (MRT) [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2003
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation A Drug: biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-21 days will take place between dosing visits
Experimental: Formulation B Drug: biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-21 days will take place between dosing visits

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620437

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Hiromasa Ono Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01620437     History of Changes
Other Study ID Numbers: BIASP-1581
Study First Received: June 13, 2012
Last Updated: June 13, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013