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

• 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 ] [ Designated as safety issue: No ]
• Maximum observed serum hGH concentration [ Time Frame: Over a 24-hour sampling period ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: No ]
• Maximum IGF-I (insulin-like growth factor-I) effect (Emax) [ Time Frame: Over a 96-hour sampling period ] [ Designated as safety issue: No ]

• 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) ] [ Designated as safety issue: No ]
• The frequency of abnormal hematology [ Time Frame: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation) ] [ Designated as safety issue: No ]
• 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) ] [ Designated as safety issue: No ]
• Biochemistry laboratory parameters [ Time Frame: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation) ] [ 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 day 13) to follow-up during the two dosing periods (day 5 and day 17) ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: No ]
• Maximum IGFBP-3 (insulin-like growth factor binding protein 3) effect (Emax) [ Time Frame: Over a 96-hour sampling period ] [ Designated as safety issue: No ]

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.

• Growth Disorder
• Healthy

• Experimental: Norditropin®
  Intervention: Drug: somatropin
• Active Comparator: Nutropin AQ®
  Intervention: Drug: somatropin

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