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

Study Overview
=================
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.

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

Conditions
-----------------
Genetic Disorder, Prader-Willi Syndrome, Growth Disorder, Idiopathic Short Stature, Healthy

Intervention / Treatment
-----------------
* Drug: somatropin
* Drug: somatropin


Participation Criteria
=================
Eligibility 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

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen<br>|
| Active Comparator: Genotropin®<br> | Drug: somatropin<br>* A single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12<br>|

What is the study measuring?
-----------------
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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 effect (Emax) |  | over a 96-hour sampling period | 
| The frequency of adverse events (AE) |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product) |