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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01401244
First received: July 20, 2011
Last updated: April 23, 2013
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Genetic Disorder
Prader-Willi Syndrome
Growth Disorder
Idiopathic Short Stature
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 Genotropin® in Healthy Adult Volunteers

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Maximum observed serum hGH concentration [ Time Frame: over a 24-hour sampling period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Maximum IGF-I effect (Emax) [ Time Frame: over a 96-hour sampling period ] [ Designated as safety issue: No ]
  • 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) ] [ 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 13, respectively) to follow-up during the two dosing periods (day 5 and 17, respectively) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: July 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Norditropin® Drug: somatropin
A single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen
Active Comparator: Genotropin® Drug: somatropin
A single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401244

Locations
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: John Germak 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: NCT01401244     History of Changes
Other Study ID Numbers: GH-3939, U1111-1121-3640
Study First Received: July 20, 2011
Last Updated: April 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dwarfism
Growth Disorders
Genetic Diseases, Inborn
Prader-Willi Syndrome
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Endocrine System Diseases
Pathologic Processes
Mental Retardation
 Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Obesity
Overnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on June 18, 2013