A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF TWO DIFFERENT INJECTOR PEN DEVICES FOLLOWING SUBCUTANEOUS ADMINISTRATION OF THE SAME GENOTROPIN® (SOMATROPIN) DOSE IN HEALTHY ADULT PARTICIPANTS
A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF TWO DIFFERENT INJECTOR PEN DEVICES FOLLOWING SUBCUTANEOUS ADMINISTRATION OF THE SAME GENOTROPIN® (SOMATROPIN) DOSE IN HEALTHY ADULT PARTICIPANTS
The purpose of this clinical study is to learn about how different injector pens affect:
The study is seeking participants who are:
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.
Inclusion Criteria:
Exclusion Criteria: