The purpose of this clinical study is to learn about how different injector pens affect: * how the study medicine (called Genotropin) is delivered into the body and * how the study medicine is taken up into the blood in healthy adults. The study is seeking participants who are: * Aged 18 to 60 years old * Male or female who are healthy as determined by medical assessment * Body-mass index (BMI) of 16 to 32, and a total body weight more than 45 kg. BMI is a way to estimate a healthy body weight for an adult's height. Adults in this study will receive study medicine by a shot under the skin. The study medicine will be given using 2 different injector pens which are medical devices that give a shot under the skin. Blood samples will be taken before and after the shots to look for the study medicine. We will compare the amount of study medicine in the blood between shots from the 2 injector pens. Adults will take part in this study for about 10 weeks including the screening period. They will have to stay at the study clinic for at least 13 days. This includes 2 study periods in total. A follow up phone call will be made 23 to 30 days following the last study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
27
Growth Hormone Delivery Device for use with Somatropin for injection
Growth Hormone Delivery Device for use with Somatropin for injection
4mg subcutaneous
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Somatropin
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Time frame: At pre-dose -24, -18, -12, -8, 0 and 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on day 1 of each period
Maximum Observed Plasma Concentration (Cmax) for Somatropin
Time frame: At pre-dose -24, -18, -12, -8, 0 and 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on day 1 of each period
Number of Participants With Treatment Emergent Adverse Events
Time frame: From start of study treatment up to 28-35 days after last dose of study treatment (41 days)
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Up to Day 11
Area under the effect-time curve from 0 to time of last measurable concentration (AUEClast)
Area under the effect-time curve to the last observed time point of Serum IGF-1
Time frame: At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period
Maximum observed effect (Emax)
Maximum observed effect of Serum IGF-1
Time frame: At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period
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