Pharmacogenomic influence of CYP2C19 genotype on Ilaprazole pharmacokinetics in Healthy South Asian population: A Single-Arm,Open-Label Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To assess the pharmacokinetic parameters (Cmax, Tmax, AUC, Clearance, and t½) of
研究概览
简要总结
Healthy south asian volunteers are recruited with informed consent.Then blood samples will be collected to perform CYP2C19 genotyping where participants are then stratified into groups as poor and extensive metabolizers of CYP2C19.Then eligible participants are then narrowed down with their general examination laboratory tests. And on the day of study necessary instructions for the study will be instructed and a single dose of the study drug will be administered in early morning on empty stomach for better absorption. After administration serial blood samples will be collected (eg: pre-dose,1h, 2h, 3h, 6h, 10h, 12h, 24h) accordingly and further samples will be processed and bioanalysis will be done by using LC-MS/MS to determine the drug concentrations in the blood and assess the PK parameters to compare between the categorized genotype groups. Vital signs and Adverse Drug Events will be monitored on the day of the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Body weight more than 50 kg, Willing to provide informed written consent and comply with study Requirements, Capable of effective communication, Non-smokers or individuals who smoke fewer than 5 cigarettes per day, Teetotalers or individuals consuming less than 60 mL of high alcohol content liquor or 120 mL of low alcohol content liquor, BMI between 18.50 and 24.99 Kg/m², Healthy based on personal history, medical history, and clinical examination, Vital parameters within the following BP: 100-139 mmHg (systolic) and 60-89 mmHg (diastolic), Pulse rate: 60-100 bpm, Temperature: 97.8°F to 99.0°F, Respiratory rate: 14-22/min, Negative tests for HIV 1, Hepatitis B, Hepatitis C, and Syphilis.
排除标准
- •Inability to understand informed consent,history of major surgical procedures in the past 3 months.
- •History of diabetes mellitus, tuberculosis, systemic hypertension, or significant disorders in major organ systems (cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, or hematological systems).
- •History of dysphagia or hypersensitivity to the study drugs, History of allergy to food or vegetables, Present or past history of drug abuse.
- •Prior use of drugs that could modify the pharmacokinetics or dynamics of the study medication.
- •Consumption of grapefruit or its products within 48 hours prior to the start of the study.
结局指标
主要结局
To assess the pharmacokinetic parameters (Cmax, Tmax, AUC, Clearance, and t½) of
时间窗: Serial blood sampling: pre dose, 1st hr, 2nd hr,4th hr, 6th hr, 10th hr and 12th hr and 24th hr
Ilaprazole among different CYP2C19 metabolizer phenotypes in healthy South Asian volunteers
时间窗: Serial blood sampling: pre dose, 1st hr, 2nd hr,4th hr, 6th hr, 10th hr and 12th hr and 24th hr
次要结局
未报告次要终点
研究者
Dr Priyadharshini A
SRM Institute of Science and Technology, Kattankulathur.