The Pharmacokinetic Comparison and Bioequivalence Evaluation of Two 10-µg Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Bioequivalency between the 2 formulations of rE-4
研究概览
简要总结
Evaluation of the pharmacokinetics and safety rE-4 Injection versus rE-4 Freeze-dried Powder in healthy subjects.
详细描述
The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects will receive a subcutaneous single dose of rE-4 (rE-4 Injection 10µg or rE-4 Freeze-dried Powder 10µg) administered 30min prior to the start time of a standard breakfast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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 adult volunteers of 18-45 years old, who can be inserted needle.
- •Body mass index (BMI) of 19 to 26 kg/m2, inclusive BMI = weight (kg)/[height(m)]2，During Screening period body weight≥50 kg.
- •Subjects are fully informed and voluntarily consent to participate in this study.
排除标准
- •A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.
- •History or presence of neurological, cardiovascular, renal, hepatic, pancreatic,gastrointestinal, pulmonary, metabolic, or musculoskeletal diseases.
- •History or presence neurological disorder disease.
- •Abnormal laboratory profiles, routine inspection, vitl signs and ECGs results with clinical significance.
- •Participation in a clinical drug study 30 days prior to present study.
- •FPG≥6.1mmol/L or <3.9mmol/L.
- •SBP<90mmHg or >140mmHg; DBP>90mmHg.
- •Use of any other drugs,vitamine and mineral substance.
- •Blood donation more than 200 mL blood within 3 months prior to the study.
- •Smoker (>5 cigarettes/day) or alcoholist (355 ml alcohol/day).
- •History or Family history of hypoglycemia.
- •History of allergy or hypersensitivity.
- •Subjects planning to give birth or donate sperm during the study or within 3 months after the study.
- •Other unfavorable factors diagnosed by investigators.
研究组 & 干预措施
rE-4 Injection
10µg, rE-4 Injection, 30 minutes prior to the start time of a standard breakfast.
干预措施: rE-4 Injection (Drug)
rE-4 Freeze-dried Powder
10µg, rE-4 Freeze-dried Powder, 30 minutes prior to the start time of a standard breakfast.
干预措施: rE-4 Freeze-dried Powder (Drug)
结局指标
主要结局
Bioequivalency between the 2 formulations of rE-4
时间窗: before injection and 0.25,0.5,0.75,1.0,1.5，2.0,3.0,4.0,6.0,8.0hour post-injection
Area under curve
次要结局
未报告次要终点