Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01512095
First received: January 9, 2012
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

This trial is conducted in Europe and United States of America (USA). The aim of this trial is to examine the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® versus Nutropin AQ® in healthy adult volunteers.


Condition Intervention Phase
Growth Disorder
Healthy
Drug: somatropin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial to Examine the Bioequivalence of Norditropin® Versus Nutropin AQ® in Healthy Adult Volunteers

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the serum hGH (human growth hormone) concentration-time curve (AUC0-t) [ Time Frame: From 0 to the time of the last quantifiable concentration over a 24-hour sampling period ] [ Designated as safety issue: No ]
  • Maximum observed serum hGH concentration [ Time Frame: Over a 24-hour sampling period ] [ Designated as safety issue: No ]
  • Area under the effect (IGF-I) curve from time 0 to the time of the last concentration (AUEC0-t) [ Time Frame: Over a 96-hour sampling period ] [ Designated as safety issue: No ]
  • Maximum IGF-I (insulin-like growth factor-I) effect (Emax) [ Time Frame: Over a 96-hour sampling period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The frequency of adverse events (AE) and vital signs [ Time Frame: From screening (14 days before randomisation) to follow-up period (3-21 days after randomisation) ] [ Designated as safety issue: No ]
  • The frequency of abnormal hematology [ Time Frame: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation) ] [ Designated as safety issue: No ]
  • The frequency of abnormal findings in physical examinations [ Time Frame: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation) ] [ Designated as safety issue: No ]
  • Biochemistry laboratory parameters [ Time Frame: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation) ] [ Designated as safety issue: No ]
  • The frequency of injection site reaction [ Time Frame: From the time of injection of the trial product (day 1 and day 13) to follow-up during the two dosing periods (day 5 and day 17) ] [ Designated as safety issue: No ]
  • Area under the effect (IGFBP-3) curve [ Time Frame: From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period ] [ Designated as safety issue: No ]
  • Maximum IGFBP-3 (insulin-like growth factor binding protein 3) effect (Emax) [ Time Frame: Over a 96-hour sampling period ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Norditropin® Drug: somatropin
A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period
Active Comparator: Nutropin AQ® Drug: somatropin
A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No previous exposure to recombinant human GH (growth hormone)or IGF-I (insulin-like growth factor-I)
  • Body mass index (BMI) 18.0-27.0 kg/m^2 (both inclusive)
  • Considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results, and electrocardiogram (ECG), as judged by the Investigator

Exclusion Criteria:

  • The receipt of any investigational medicinal product within 1 month prior to this trial
  • Current or previous treatment with recombinant human growth hormone or IGF-I
  • Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures as required by local law) for the duration of the trial
  • Known presence or history of malignancy
  • Diabetes mellitus
  • Use of pharmacologic doses of glucocorticoids
  • Use of anabolic steroids
  • History of drug or alcohol abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512095

Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: John Germak Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01512095     History of Changes
Other Study ID Numbers: GH-3958, 2012-003381-40, U1111-1122-9661
Study First Received: January 9, 2012
Last Updated: September 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014