Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pharmacokinetics Assessment
研究概览
简要总结
The objective of this study was to compare pharmacokinetic of Lansoprazole Capsules 30 mg with Lansoprazole Capsules of Takeda 30 mg in healthy adult human subjects.
详细描述
i. randomized, open label, single-dose, two-treatment, three-period,partial replicate pharmacokinetic study of Lansoprazole 30 mg Capsules of Beijing Sihuan Pharm, comparing with that of Lansoprazole enteric-coated Capsules 30 mg of Takeda Pharmaceutical Company Limited in healthy, adult, human subjects under fasting conditions.
ii. randomized, open label, single dose, two-period, pharmacokinetic study of Lansoprazole 30 mg Capsules of Beijing Sihuan Pharm in healthy, adult, human subjects under fasting/fed conditions.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject who were healthy, adult, human beings within 18 and 60 years of age (both inclusive)
- •Male (weight ≥50kg) or female (weight ≥45kg); Subject having a body mass index between 19.0 and 26.0 (both inclusive), calculated as weight in Kg/height in m
- •Subject who totally understand the aim, procedure, benefits and adverse effects of this clinical trial, make decision by his/her free will, and sign a consent form to follow the progress;
- •The participant could communicate well with investigator, comply with and finish the study according to the procedure.
排除标准
- •Subject who has past or present history of any serious diseases, including (but not limited to) digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, psychiatric or neurological, hematologic, immunological or metabolic disorders;
- •Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator;
- •Intake of over the counter (OTC) or prescribed medications or vitamins or any traditional medicine products for the last 14 days before first dosing.
- •Has a special requirement for food and cannot adhere to a uniform diet or swallowing victims.
- •Venous puncture intolerable and/or blood phobia
- •Abused of tea, coffee and caffeine-contained beverages; or taking caffeine/xanthene containing food or beverages (like tea, coffee, chocolates and cola drinks) for the last 48 hrs before first dosing.
- •Habit of alcoholism; or frequent drinkers for the last 6 months before screening; or intake of any alcoholic products for the last 24 hrs before first dosing.
- •Regular smoker who has a habit of smoking more than five cigarettes per day for the last 3 months and has difficulty in abstaining from smoking during sample collection period.
- •Blood donation or blood loss ≥ 450 mL for the last 3 months before first dosing; or plan to donate blood or blood composition during the study or 3 months after the end of the study.
- •Intake of any enzyme modifying food or beverages for the last 48 hrs before first dosing.
- •Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study; or subjects declined to practice non-pharmacologic prevention of birth control during the study.
- •Abused of drugs or Intake of drugs for the last 3 months before screening.
- •Subjects who had participated in any other clinical investigation using experimental drug/medical instrument/diagnostic reagent in past 3 months before screening.
- •Clinically significant abnormalities judged by investigators during screening test.
- •Confirmed positive in alcohol screening, smoking screening or selected drug of abuse.
- •Human immunodeficiency virus(HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or syphilis positive.
- •Other reasons for non-inclusion judged by investigator.
研究组 & 干预措施
Lansoprazole Capsules
Lansoprazole Capsules 30 mg of Beijing Sihuan Pharm
干预措施: Lansoprazole capsules (Drug)
Lansoprazole enteric-coated Capsules
Lansoprazole enteric-coated Capsules 30 mg of Takeda Pharmaceutical Company Limited
干预措施: Lansoprazole capsules (Drug)
结局指标
主要结局
Pharmacokinetics Assessment
时间窗: 16 hrs post-dose on day 1.
1. Cmax: Maximum Observed Plasma Concentration for lansoprazole Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. \[Time Frame: 16 hours post-dose on Day 1\] 2. TmaxTime to Reach the Maximum Plasma Concentration \[Time Frame: 16 hours post-dose on Day 1\] 3. AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for lansoprazole AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity \[Time Frame: Time Frame: 16 hours post-dose on Day 1\] 4. AUC(0-16h): Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for lansoprazoleAUC(0-36h) is measure of area under the plasma concentration and time curve from Time 0 to 36 hours postdose. \[Time Frame: 16 hours post-dose on Day 1\] model.
次要结局
未报告次要终点