Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC0-t)
研究概览
简要总结
an open label,balanced,randomized,two-treatment,two-period,two-sequence,single dose,crossover,oral bioequivalence Study of oseltamivir phosphate for oral suspension in healthy ,adult,human subjects under fasted/fed conditions.
详细描述
72 healthy adult subjects will be enrolled and randomized in the study.In each period,total 21 venous blood samples (3ml each)will be collected at 0h，10min,20min,30min,45min,1h,1.25h,1.5h,1.75h,2h,2.25h,2.5h,3h,3.5h,4h,4.5h,5h,6h,8h,12h,24h,36h.
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
盲法说明
open
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are able to give the signed ICF before the study, and fully understand the study content, process and possible adverse reactions; 2) Subjects are able to complete the study in compliance the study in compliance with the protocol; 3) Subjects (including male subjects) agree to adopt effective contraceptive methods and not plan to get pregnant or to donate sperm or ovum from 14 days before screening to 3 months after study completion; 4) Healthy male and female subjects above 18 years of age ( inclusive); 5) Male subjects who are at least 50 kg and female subjects who are at least 45 kg, with a Body Mass Index (BMI)= Weight/Height2 (kg/m2) between 19.0-26.0 kg/m2 (both inclusive);
排除标准
- •History of specific allergies (asthma, etc.), allergies (such as those who are allergic to two or more drugs, foods such as milk or pollen), or hypersensitivity to Oseltamivir Phosphate or any excipients or related class of drugs
- •People with rare hereditary galactose intolerance or fructose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase deficiency;
- •No history of cardiac, hepatic, renal, digestive tract, nervous system, mental and metabolic disorders, etc.;
- •History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption;
- •History of surgery within 3 months prior to first dosing;
- •5 or more cigarettes per day on average within 3 months before the screening;
- •Use of any drugs within 14 days prior to dosing
研究组 & 干预措施
Oseltamivir Phosphate For Oral Suspension/Tamiflu
Tamiflu ,6mg/ml,batch no.3235821,manufactured by F.Hoffmann-La Roche Ltd.
干预措施: Oseltamivir Phosphate For Oral Suspension/Tamiflu (Drug)
Oseltamivir Phosphate For Oral Suspension
6mg/ml,batch no.GH1A0003,manufactured by Qilu Pharmaceutical(Hainan) Co., Ltd.
干预措施: Oseltamivir Phosphate For Oral Suspension (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC0-t)
时间窗: up to 1 year
Evaluation of Area under the plasma concentration versus time curve (AUC0-t)
Area under the plasma concentration versus time curve (AUC0-∞)
时间窗: up to 1 year
Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)
Peak Plasma Concentration (Cmax)
时间窗: up to 1 year
Evaluation of Peak Plasma Concentration (Cmax)
Bioequivalence
时间窗: up to 1 year
Analysis of variance (ANOVA) was performed after logarithmic conversion of main pharmacokinetic parameters (Cmax, AUC) to calculate 90% confidence interval of geometric mean ratio of main pharmacokinetic parameters of the two preparations, and equivalence comparison was conducted. The equivalent interval was set to 80.00%\~125.00%
次要结局
- Incidence of Treatment-Emergent Adverse Events(up to 1 year)