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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period
A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period
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
Maximum observed serum hGH concentration
Time frame: 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)
Time frame: Over a 96-hour sampling period
Maximum IGF-I (insulin-like growth factor-I) effect (Emax)
Time frame: Over a 96-hour sampling period
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)
The frequency of abnormal hematology
Time frame: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)
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)
Biochemistry laboratory parameters
Time frame: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)
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)
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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
Maximum IGFBP-3 (insulin-like growth factor binding protein 3) effect (Emax)
Time frame: Over a 96-hour sampling period