A Study to Learn How Different Injector Pens Affect the Study Medicine Called Genotropin (Somatropin) Delivery and Taken up Into the Blood in Healthy Adults
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
Pfizer
26 participants
Apr 22, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- Healthy Participants
- BMI 16 to 32 kg/m2
- body weight more than 45kg
Exclusion Criteria4
- Ongoing or past history of significant medical conditions
- Use of prescription or non prescription medications within 14 days of first study dose
- Previous exposure to growth hormone
- History of alcohol abuse, binge drinking or illicit drug use
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Growth Hormone Delivery Device for use with Somatropin for injection
Growth Hormone Delivery Device for use with Somatropin for injection
4mg subcutaneous
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07542886