Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Peak drug concentration (Cmax) of paracetamol
研究概览
简要总结
The objective of the study is to compare the bioavailability of a generic product of paracetamol (immediate-release) with that of a reference product when administered to healthy volunteers under fasting condition. The test product is Fortolin Tab 500mg manufactured by Fortune Pharmacal Co. Ltd., and the reference product is Panadol Caplet 500mg manufactured by GlaxoSmithKline (Dungarvan) Ltd. The plasma pharmacokinetic data of paracetamol obtained from two formulations will be used to evaluate the interchangeability of the products.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and non-pregnant female, 18 to 55 years of age
- •Body Mass Index (BMI) between 18 to 25 kg/m2
- •Accessible vein for blood sampling
- •High probability for compliance and completion of the study
- •Female subjects who are surgically sterile or post-menopausal. Or female subjects of child bearing potential agree to practice abstinence or take effective contraceptive methods (e.g.implanted contraceptives, intra-uterine device or consistent condom plus spermicide use) from the start of screening until two weeks of last dose administration to prevent pregnancy.
- •Have signed the written informed consent to participate in the study.
排除标准
- •Clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, psychiatric, metabolic and other diseases
- •Clinically significant abnormality in physical examination, vital signs, laboratory test results and ECG evaluation
- •Positive results of hepatitis B
- •Moderate smoker (more than 2 cigarettes a day within 3 months prior to the start of first dosing)
- •Moderate consumption of alcohol (more than one drink per day within 3 months prior to the start of first dosing)
- •Have lost or donated more than 350 ml of blood within 3 months prior to the start of first dosing
- •Subjects who are taking prescription or non-prescription medications (except for contraceptives, refer to "Inclusion Criteria" section) which is likely to be required during the course of the study
- •Use of paracetamol or other analgesic/antipyretic medications within 4 weeks before first dosing
- •Volunteer in any other clinical drug study within 2 months prior to the start of first dosing
- •Hypersensitivity to paracetamol or other drugs in its class
- •History of drug abuse in any form
- •Female subjects who are breastfeeding or pregnant
- •Subjects who are considered not suitable in participating the study due to other factors judged by investigators
研究组 & 干预措施
Panadol Caplet 500mg
During the study session, healthy subjects will be administered a single oral dose of Panadol Caplet 500mg after an overnight fast of approximately 10 hours.
干预措施: Panadol Caplet 500mg (Drug)
Fortolin Tab 500mg
During the study session, healthy subjects will be administered a single oral dose of Fortolin Tab 500mg after an overnight fast of approximately 10 hours.
干预措施: Fortolin Tab 500mg (Drug)
结局指标
主要结局
Peak drug concentration (Cmax) of paracetamol
时间窗: 12 hours
Area under the drug plasma concentration-time curve (AUC) of paracetamol
时间窗: 12 hours
次要结局
- Terminal elimination half-life (t1/2) of paracetamol(12 hours)
- Time to maximum concentration (Tmax) of paracetamol(12 hours)