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Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT01401244
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE July 20, 2011
First Posted Date  ICMJE July 25, 2011
Last Update Posted Date February 24, 2017
Actual Study Start Date  ICMJE July 14, 2011
Actual Primary Completion Date September 27, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2011)
  • Area under the serum hGH (human growth hormone) concentration-time curve [ Time Frame: from 0 to the time of the last quantifiable concentration over a 24-hour sampling period ]
  • Maximum observed serum hGH concentration [ Time Frame: over a 24-hour sampling period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2011)
  • Area under the effect (IGF-I) curve [ Time Frame: from time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period ]
  • Maximum IGF-I effect (Emax) [ Time Frame: over a 96-hour sampling period ]
  • The frequency of adverse events (AE) [ Time Frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product) ]
  • The frequency of injection site reaction [ Time Frame: from the time of injection of the trial product (day 1 and 13, respectively) to follow-up during the two dosing periods (day 5 and 17, respectively) ]
  • Abnormal hematology laboratory parameters [ Time Frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product) ]
  • Abnormal biochemistry laboratory parameters [ Time Frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product) ]
  • Abnormal findings in physical examinations [ Time Frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product) ]
  • Vital signs [ Time Frame: from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers
Official Title  ICMJE A Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult Volunteers
Brief Summary This trial is conducted in United States of America (USA). The aim of this trial is to examine the bioequivalence of Norditropin® versus Genotropin® in healthy adult volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Genetic Disorder
  • Prader-Willi Syndrome
  • Growth Disorder
  • Idiopathic Short Stature
  • Healthy
Intervention  ICMJE
  • Drug: somatropin
    A single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen
  • Drug: somatropin
    A single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12
Study Arms  ICMJE
  • Experimental: Norditropin®
    Intervention: Drug: somatropin
  • Active Comparator: Genotropin®
    Intervention: Drug: somatropin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2011)
30
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2011)
26
Actual Study Completion Date  ICMJE September 27, 2011
Actual Primary Completion Date September 27, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 (trial physician)

Exclusion Criteria:

  • The receipt of any investigational medicinal product within 1 month prior to this trial
  • Current or previous treatment with growth hormone or IGF-I (insulin-like growth factor-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 or practice) 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01401244
Other Study ID Numbers  ICMJE GH-3939
U1111-1121-3640 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date February 2017

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