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Предстои набиране Фаза 1 NCT07542886

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

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Healthy

Спонсор: Pfizer

Налично на: БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria: * Healthy Participants * BMI 16 to 32 kg/m2 * body weight more than 45kg Exclusion Criteria: * 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
Интервенции
Marketed Genotropin Pen 12
DEVICE
New Genotropin Injector Pen
DEVICE
Genotropin 4mg
DRUG
Места на провеждане

Информация за локации не е налична.

Технически детайли
Статус
Предстои набиране
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
60 Years
Здрави доброволци
Не
Начална дата
22.04.2026
Крайна дата
22.07.2026
Регистрационен номер
NCT07542886
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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