Pharmacokinetics of a Standard Paracetamol Tablet and Oral Solution After Oral Administration in Chinese Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 主要终点
- AUC
研究概览
简要总结
Drug dissolution in vivo play a crucial role for the bioavailability and therapeutic of an orally administered solid dosage form. The aim of this study was to evaluate the pharmacokinetics of a standard paracetamol tablet in comparison with oral solution in Chinese healthy volunteers. Based on the Noyes-Whitney equation and pharmacokinetics parameters, investigators trend to propose a method to estimate in vivo dissolution time and dissolution kinetics of solid dosage form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 25 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Sex: Male or female (limited to PK study)
- •Healthy volunteers, age: 18-45（medical history, physical examination, vital signs, ECG and lab tests are qualified during screening）
- •Body Mass Index（BMI）:19~24 or body weight is not less than 50Kg
- •Non-pregnant women confirmed by pregnancy test
- •Vital Signs: after 3 minutes supination, the following measurements criteria should be within ranges: body temperature (axillary temperature), 36.0~37.0 ℃; blood pressure, SBP 90~140mmHg（12.0~18.7kpa）and DBP 60~90mmHg（8.0~12.0kpa）; arterial pulse: 60~100 bpm
- •Non-hypersensitivity to this product or its similar product
- •Non-smoker, non-alcoholic
- •Subject must be able to sign Inform Consent prior to participation into this study
- •Subject must be able to communicate with investigator and comply with study protocol.
排除标准
- •Subjects meet with one or several of the following criteria should be excluded:
- •Subjects failed in physical examination
- •Pregnant or nursing women
- •Administration of a known drug that can cause damage to organs within 3 months
- •Administration of any prescription drug or non-prescription drug 2 weeks before initial dose
- •Before initial dose, participation in any other clinical trials within 3 months
- •Blood donation 3 months before this study, or plan to have blood donation during or one month after this study
- •Diagnosis of clinical evident diseases 2 weeks before initial dose
- •Primary diseases to vital organs
- •Physically or mentally disabled
- •Medical history of specific allergy (asthma, measles, eczematous dermatitis), or known to allergic to similar (including excipients)
- •Any other surgical or internal medicinal conditions that might cause damage to study subjects or will change the absorption, distribution, metabolism and elimination of investigational drug, including:
- •inflammatory intestinal syndrome, peptic ulcer, alimentary tract hemorrhage
- •a history of severe gastrointestinal tract operation, such as gastrectomy, gastrosmoty / jejunostomy or large bowel resection
- •a history of hepatic disease or laboratory examination findings such as ALT, AST, γ-GT or T-Bili showing clinically significant abnormalities to liver
- •a history of renal disease or laboratory examination findings such as creatinine, urea nitrogen, or albuminuria showing clinically significant abnormalities to kidney
- •urination disorder or dysuresia.
- •A history of immunological deficiency disease, or HIV positive
- •HBV or HCV positive
- •Women undergone menstrual period during study
- •Consumption of a significant amount of smoking or drinking, that is drinking more than 28 units of alcohol per week (1 unit: 285ml of beer, 25ml of liquor, or 1 glass of wine), or smoking more than 2 cigarettes
- •Frequent use of sedatives, hypnotics, stabilizers or other addictive drugs
- •Consumption of more than 8 cups of tea, coffee, and or caffeine beverages
- •Unable to complete this study for any others reasons.
- •Investigators.
研究组 & 干预措施
paracetamol oral solution
dosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose
干预措施: paracetamol oral solution (Drug)
paracetamol tablet
dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose
干预措施: paracetamol tablet (Drug)
结局指标
主要结局
AUC
时间窗: one month
AUC:the area under the concentration-time curve
Cmax
时间窗: one month
Cmax: maximum plasma concentration
Tmax
时间窗: one month
Tmax: the time point of maximum plasma concentration
MRT
时间窗: one month
MRT: mean residence time
次要结局
未报告次要终点
研究者
Feifan Xie
Institute of Drug Metabolism and Pharmacokinetics,School of Pharmaceutical Sciences,Central South University
Central South University