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

Study Overview
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Brief Summary
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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.

Official Title
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A Trial to Examine the Bioequivalence of Norditropin® Versus Nutropin AQ® in Healthy Adult Volunteers

Conditions
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Growth Disorder, Healthy

Intervention / Treatment
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* Drug: somatropin
* Drug: somatropin


Participation Criteria
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Eligibility Criteria
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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

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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No

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: somatropin<br>* A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period<br>|
| Active Comparator: Nutropin AQ®<br> | Drug: somatropin<br>* A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out 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 (AUC0-t) |  | 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) curve from time 0 to the time of the last concentration (AUEC0-t) |  | Over a 96-hour sampling period | 
| Maximum IGF-I (insulin-like growth factor-I) effect (Emax) |  | Over a 96-hour sampling period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of adverse events (AE) and vital signs |  | From screening (14 days before randomisation) to follow-up period (3-21 days after randomisation) | 
| The frequency of abnormal hematology |  | From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation) | 
| The frequency of abnormal findings in physical examinations |  | From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation) | 
| Biochemistry laboratory parameters |  | From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation) | 
| The frequency of injection site reaction |  | 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) | 
| Area under the effect (IGFBP-3) curve |  | From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period | 
| Maximum IGFBP-3 (insulin-like growth factor binding protein 3) effect (Emax) |  | Over a 96-hour sampling period |