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A Comparison Between Two Formulations of NN5401 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01125553
First received: May 7, 2010
Last updated: August 30, 2012
Last verified: May 2012
History of Changes
  Purpose

This trial is conducted in the United States of America (USA). The aim of the trial is to compare the exposure of two formulations of NN5401 in healthy subjects.


Condition Intervention Phase
Diabetes
Healthy
 Drug: NN5401
 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 Trial to Test for Bioequivalence Between Two NN5401 Formulations in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the serum insulin degludec concentration-time curve [ Time Frame: from 0 to 120 hours after single-dose ] [ Designated as safety issue: No ]
  • Maximum observed serum insulin degludec concentration [ Time Frame: from 0 to 120 hours after single-dose ] [ Designated as safety issue: No ]
  • Area under the serum insulin aspart concentration-time curve [ Time Frame: from 0 to 12 hours after single-dose ] [ Designated as safety issue: No ]
  • Maximum observed serum insulin aspart concentration [ Time Frame: from 0 to 12 hours after single-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to maximum observed serum insulin degludec concentration [ Time Frame: from 0 to 120 hours after single-dose ] [ Designated as safety issue: No ]
  • Time to maximum observed serum insulin aspart concentration [ Time Frame: from 0 to 12 hours after single-dose ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: May 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NN5401 - formulation A Drug: NN5401
Each subject will be allocated to 2 single injections of trial product on 2 separate dosing visits with each of the 2 NN5401 formulations (NN5401 contains both insulin degludec and insulin aspart). The trial products will be administered as a subcutaneous injection (under the skin)
Experimental: NN5401 - formulation B Drug: NN5401
Each subject will be allocated to 2 single injections of trial product on 2 separate dosing visits with each of the 2 NN5401 formulations (NN5401 contains both insulin degludec and insulin aspart). The trial products will be administered as a subcutaneous injection (under the skin)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Considered generally healthy upon completion of medical history, physical examination, vital signs and ECG, as judged by the physician
  • Body mass index between 18.0 and 27.0 kg/m2 (both inclusive)

Exclusion Criteria:

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
  • Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125553

Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: DJ Chatterjee, Ph.D Novo Nordisk
  More Information

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

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01125553     History of Changes
Other Study ID Numbers: NN5401-1980, U1111-1113-7011
Study First Received: May 7, 2010
Last Updated: August 30, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 17, 2013