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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
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.
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.
Novo Nordisk Clinical Trial Call Center
Overland Park, Kansas, United States
Area under the serum hGH (human growth hormone) concentration-time curve
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) (insulin-like growth factor-I) curve
Time frame: 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)
Time frame: Over a 96-hour sampling period
The frequency of adverse events (AE)
Time frame: From screening to follow-up period (up to day 23)
Abnormal haematology laboratory parameters
Time frame: From screening to follow-up period (up to day 23)
Abnormal biochemistry laboratory parameters
Time frame: From screening to follow-up period (up to day 23)
The frequency of injection-site reactions
Time frame: 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
Time frame: From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period
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Maximum IGFBP-3 effect (Emax)
Time frame: Over a 96-hour sampling period
Abnormal findings in vital signs
Time frame: From screening to follow-up period (up to day 23)
Abnormal findings in physical examinations
Time frame: From screening to follow-up period (up to day