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

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ClinicalTrials.gov Identifier: NCT01512095
Recruitment Status : Withdrawn
First Posted : January 19, 2012
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Growth Disorder Healthy Drug: somatropin Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial to Examine the Bioequivalence of Norditropin® Versus Nutropin AQ® in Healthy Adult Volunteers
Study Start Date : August 2013
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Maximum observed serum hGH concentration [ Time Frame: Over a 24-hour sampling period ]
  3. 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 ]
  4. Maximum IGF-I (insulin-like growth factor-I) effect (Emax) [ Time Frame: Over a 96-hour sampling period ]

Secondary Outcome Measures :
  1. 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) ]
  2. The frequency of abnormal hematology [ Time Frame: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation) ]
  3. 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) ]
  4. Biochemistry laboratory parameters [ Time Frame: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation) ]
  5. 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) ]
  6. 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 ]
  7. Maximum IGFBP-3 (insulin-like growth factor binding protein 3) effect (Emax) [ Time Frame: Over a 96-hour sampling period ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512095


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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01512095     History of Changes
Other Study ID Numbers: GH-3958
2012-003381-40 ( EudraCT Number )
U1111-1122-9661 ( Other Identifier: WHO )
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes