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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This study has been withdrawn prior to enrollment.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

January 9, 2012
September 13, 2013
August 2013
November 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01512095 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers
A Trial to Examine the Bioequivalence of Norditropin® Versus Nutropin AQ® in Healthy Adult Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Growth Disorder
  • Healthy
Drug: somatropin
A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period
  • Experimental: Norditropin®
    Intervention: Drug: somatropin
  • Active Comparator: Nutropin AQ®
    Intervention: Drug: somatropin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01512095
GH-3958, 2012-003381-40, U1111-1122-9661
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: John Germak Novo Nordisk A/S
Novo Nordisk A/S
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP