CTRI/2021/10/037480已完成不适用
A Phase 1 single Centre randomized double blind placebo controlled Clinical Pharmacokinetic drug interaction study between simvastatin and PeaNoc XL in Adult Healthy Human volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- This study is designed to evaluate the drug interaction potential of multiple oral doses of PeaNoc XL based on the pharmacokinetic parameters (AUC, Cmax, Tmax, t1/2, CL, Vd) changes of simvastatin.
研究概览
简要总结
PeaNoc XLhas been used for the treatment of inflammatory and chronic pain etc. However, the information regarding the ADME parameter and drug interaction potential ofPeaNoc XLhave not been investigated and hence the present study aimed to determine the drug interaction potential ofPeaNoc XL****by estimating the pharmacokinetic parameters (AUC, Cmax, Tmax, t1/2, CL, Vd.) changes of simvastatin
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •â€¢ Healthy male volunteers of 18-45 years (both years inclusive) and body weight > 50 kg. • Willing to give informed written consent and comply with the study requirements. • Subject should be able to communicate effectively. • Non-smokers or individuals who smoke less than 5 cigarettes per day • Teetotalers or individuals who drink less than 60 ml of high-alcohol-content liquor or 120 ml of low-alcohol-content liquor • Body Mass Index (BMI) between 18.50 and 24.99 Kg/m2 • Healthy individuals as evaluated by personal history, medical history and general clinical examination. • Vital parameters.
- •BP should be within the range of 100 – 139 mmHg systolic and 60 – 89 mmHg diastolic. Pulse rate should be within the range of 60 – 100 / min. Oral temperature between 97.8Ëš F and 99.0 Ëš F. Respiratory rate should be within the range of 14-18/min. • Normal biochemical, hematological and urinary parameters. • Normal Chest X-ray PA view & ECG in 12 leads. • Negative for HIV 1 & 2, Hepatitis B, Hepatitis C and Syphilis tests. • Negative urine test for drugs of abuse for morphine, barbiturates, benzodiazepines, amphetamine, THC & cocaine (to be performed on the day of check-in). • Negative alcohol breath analysis (to be performed on the day of check-in).
排除标准
- •History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric or hematological systems, judged to be clinically significant 2) subjects incapable of understanding the informed consent and not willing to participate in the study 3) hypersensitivity to study formulation 4) history of drug abuse 5) history of hypersensitivity to study drug and allergic to any vegetables or foods.
结局指标
主要结局
This study is designed to evaluate the drug interaction potential of multiple oral doses of PeaNoc XL based on the pharmacokinetic parameters (AUC, Cmax, Tmax, t1/2, CL, Vd) changes of simvastatin.
时间窗: 18weeks
次要结局
- Monitoring adverse Drug reactions during the study period(16weeks)
研究者
研究点 (1)
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