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Comparison of Two NN1250 Formulations in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00966368
First received: August 25, 2009
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

This trial is conducted in North America. The aim of this clinical trial is to investigate if two formulations of NN1250 have the same level of drug exposure to the body.


Condition Intervention Phase
Diabetes
Healthy
 Drug: NN1250
 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 NN1250 Formulations in Healthy Subjects

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the NN1250 concentration-time curve from 0 to 120 hours after single dose [ Time Frame: within 0 to 120 hours after dosing ] [ Designated as safety issue: No ]
  • Maximum observed NN1250 concentration after single dose [ Time Frame: within 0 to 120 hours after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to maximum observed NN1250 concentration after single dose [ Time Frame: within 0 to 120 hours after dosing ] [ Designated as safety issue: No ]
  • Area under the NN1250 concentration-time curve from 0 to 24 hours after single dose [ Time Frame: from 0-24 hours after dosing ] [ Designated as safety issue: No ]
  • Terminal half-life for NN1250 [ Time Frame: within 0 to 120 hours after dosing ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: August 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN1250
Single dose of NN1250, formulation 1, 0.4U/kg body weight injected subcutaneously (under the skin)
Experimental: B Drug: NN1250
Single dose of NN1250, formulation 2, 0.4U/kg body weight injected subcutaneously (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:

  • Generally healthy
  • Body Mass Index (BMI): 18.0-27.0 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 participation
  • 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: NCT00966368

Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Chula Vista, California, United States, 91911-1350
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: D. J. Chatterjee, PhD. 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: NCT00966368     History of Changes
Other Study ID Numbers: NN1250-1988, U1111-1122-2992, 2011-002949-35, P/44/2010, P/96/2011
Study First Received: August 25, 2009
Last Updated: June 29, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 16, 2013