A Randomized, Open-lable, Single-dose, 3-sequence, 3-period Crossover Bioequivalence Study of Two Different PEG-rhGH Preparations in Chinese Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation
研究概览
简要总结
The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male aged ≥18 years old and≤45 years old;
- •The Body mass index (BMI): 19-26 kg/m2 (inclusive), and body weight ≥50 kg;
- •Normal results of physical examination, vital signs, laboratory tests, 12 lead-ECG, chest X-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above.
排除标准
- •Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing;
- •Subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or other diseases deemed unsuitable for participation in the trials by the investigators;
- •Subjects with severe infection, severe trauma, or major surgery prior to screening;
- •Subjects who have received blood transfusions, had blood donors, or lost blood before screening;
- •Subjects who have positive results of human immunodeficiency virus antibodies (HIV-Ab), or hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab), or syphilis specific antibodies (TPPA);
- •Subjects who have participated in clinical trials for medication or medical device prior to screening;etc.
研究组 & 干预措施
TRR
Administration order: PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R)
干预措施: PEG-rhGH with new preparation (T) (Drug)
TRR
Administration order: PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R)
干预措施: PEG-rhGH with present preparation (R) (Drug)
RTR
Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R)
干预措施: PEG-rhGH with new preparation (T) (Drug)
RTR
Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R)
干预措施: PEG-rhGH with present preparation (R) (Drug)
RRT
Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T)
干预措施: PEG-rhGH with new preparation (T) (Drug)
RRT
Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T)
干预措施: PEG-rhGH with present preparation (R) (Drug)
结局指标
主要结局
Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation
时间窗: 0 hours -192 hours post-administration
Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation
时间窗: 0 hours -192 hours post-administration
Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0- last )) of PEG-rhGH with present and new preparation
时间窗: 0 hours -192hours post-administration
次要结局
- Safety and tolerability（Number of participants with treatment-related adverse events）(up to approximately 83 days)