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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Somatropin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Participants
- •BMI 16 to 32 kg/m2
- •body weight more than 45kg
排除标准
- •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
研究组 & 干预措施
Sequence 1
Single dose of 4 milligrams (mg) subcutaneous genotropin via marketed genotropin pen 12 (Reference) followed by single dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test)
干预措施: Genotropin 4mg (Drug)
Sequence 2
Single dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test) followed by single dose of 4mg subcutaneous genotropin via marketed genotropin pen 12 (Reference)
干预措施: Marketed Genotropin Pen 12 (Device)
Sequence 2
Single dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test) followed by single dose of 4mg subcutaneous genotropin via marketed genotropin pen 12 (Reference)
干预措施: Genotropin 4mg (Drug)
Sequence 1
Single dose of 4 milligrams (mg) subcutaneous genotropin via marketed genotropin pen 12 (Reference) followed by single dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test)
干预措施: New Genotropin Injector Pen (Device)
Sequence 2
Single dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test) followed by single dose of 4mg subcutaneous genotropin via marketed genotropin pen 12 (Reference)
干预措施: New Genotropin Injector Pen (Device)
Sequence 1
Single dose of 4 milligrams (mg) subcutaneous genotropin via marketed genotropin pen 12 (Reference) followed by single dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test)
干预措施: Marketed Genotropin Pen 12 (Device)
结局指标
主要结局
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Somatropin
时间窗: 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
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).
Maximum Observed Plasma Concentration (Cmax) for Somatropin
时间窗: 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
次要结局
- Number of Participants With Treatment Emergent Adverse Events(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(Up to Day 11)
- Area under the effect-time curve from 0 to time of last measurable concentration (AUEClast)(At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period)
- Maximum observed effect (Emax)(At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period)