A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects

Study Overview
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Brief Summary
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This trial is conducted in the United States of America (USA). The aim of the trial is to investigate the bioequivalence (the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® (somatropin) versus Genotropin® (somatropin) in healthy adult subjects.

Official Title
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A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects

Conditions
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Growth Disorder, Healthy

Intervention / Treatment
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* Drug: Norditropin® FlexPro® pen
* Drug: Genotropin Pen®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects at trial entry with no previous exposure to recombinant human 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 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 or practice) for the duration of the trial Known presence or history of malignancy Diabetes mellitus Use of systemic corticosteroids Use of anabolic steroids History of drug or alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Norditropin®<br> | Drug: Norditropin® FlexPro® pen<br>* Administered as a single subcutaneous (s.c., under the skin) dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.<br>|
| Active Comparator: Genotropin®<br> | Drug: Genotropin Pen®<br>* Administered as a single subcutaneous dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum hGH (human growth hormone) concentration-time curve |  | From 0 to the time of the last quantifiable concentration over a 24-hour sampling period. | 
| Maximum observed serum hGH concentration |  | Over a 24-hour sampling period | 
| Area under the effect (IGF-I) (insulin-like growth factor-I) curve |  | From time 0 to the time of the last measurable concentration (AUEC0-t) (area under the effect curve) over a 96-hour sampling period | 
| Maximum IGF-I effect (Emax) |  | Over a 96-hour sampling period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of adverse events (AE) |  | From screening to follow-up period (up to day 23) | 
| Abnormal haematology laboratory parameters |  | From screening to follow-up period (up to day 23) | 
| Abnormal biochemistry laboratory parameters |  | From screening to follow-up period (up to day 23) | 
| The frequency of injection-site reactions |  | From the time of injection of the trial product to follow-up during the 2 dosing periods (on Days 1 through 5, with visit 7 as follow-up and separately on Days 13 through 17, with visit 12 as follow-up for each period) | 
| Area under the effect (IGFBP-3) (insulin-like growth factor binding protein 3) curve |  | From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period | 
| Maximum IGFBP-3 effect (Emax) |  | Over a 96-hour sampling period | 
| Abnormal findings in vital signs |  | From screening to follow-up period (up to day 23) | 
| Abnormal findings in physical examinations |  | From screening to follow-up period (up to day |