Assessment of Metabolism mediated Pharmacokinetic Interactions and Therapeutic Potential of Chandraprabha vati with Glimepiride

SRM College of Pharmacy SRM Institute of Science and Technology1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2024年5月13日最近更新: 2024年3月27日

试验速览

阶段: Unknown
状态: 尚未招募
发起方
入组人数: 24
试验地点: 1
主要终点: 1 To determine the effect of multiple oral doses of Chandraprabha vati on the single dose Glimepiride administered in healthy adult volunteers

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

1 The most Human drug interaction studies so far have examined PK interactions and have been limited to very few conventional drugs and herbal drugs. This study focuses on PK interactions and Therapeutic potential of Herbal drug with Conventional drug.

2 There has been a drastic increase in herb-drug interactions day-by-day as a result of an increase in the population using herb and its supplements along with the conventional medicines. WHO estimates that 80% world populations use herbal medicines for some aspects for primary health care .

3 More than 60% Asians resort to herbal products to treat a variety of chronic disorders such as metabolic disorder, anxiety, depression, dementia and memory impairment, headache, weight loss, PCOD etc. About one in three concurrent users was at risk of a potential herbâ€“drug or supplementâ€“drug interaction.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Double

入排标准

年龄范围: 18.00 Year(s) 至 45.00 Year(s)（—）
性别: Male

入选标准

•1 Willing to give informed written consent and comply with the study requirements 2 Subject should be able to communicate effectively 3 Non smokers or individuals who smoke less than 5 cigarettes per day 4 Teetotalers or individuals who drink less than 60 ml of high alcohol content liquor or 120 ml of low-alcohol content liquor 5 Body Mass Index between 19 to 25 6 Healthy individuals as evaluated by personal history medical history and general clinical examination 7 BP should be within the range of 100 to 139 systolic and 60 to 89 diastolic Pulse rate should be within the range of 60 to 100 beats per minute Temperature between 97.8 and 99.0 degree Respiratory rate should be within the range of 14 to 18 breaths per minute 8 Normal biochemical hematological and urinary parameters 9 Normal Chest X ray 10 Negative for sexually transmitted diseases Hepatitis B Hepatitis C and Syphilis tests 11 Negative urine test for drugs of abuse for morphine barbiturates benzodiazepines amphetamine cocaine to be performed on the day of check in 12 Negative alcohol breathe analysis to be performed on the day of check in.

排除标准

•1 Subjects incapable of understanding the informed consent 2 History of any major surgical procedure in the past 3 months 3 History of diabetes mellitus tuberculosis and systemic hypertension 4 History suggestive of cardiac gastrointestinal respiratory hepatic renal endocrine neurological metabolic psychiatric or haematological systems judged to be clinically significant 5 History of dysphagia 6 History of any medical disorder that is of significance in the investigators opinion 7 Present or past history of drug abuse 8 History of hypersensitivity to study formulation 9 History of allergy to vegetables and or food substances and or any other manifestations suggestive of hypersensitivity reactions 10 Present or past history of intake of drugs which potentially modify kinetics or dynamics of study medication or any other medication judged to be clinically significant by the investigator 11 Consumption of grapefruit or its products within 48 hours prior to the start of the study.

结局指标

主要结局

1 To determine the effect of multiple oral doses of Chandraprabha vati on the single dose Glimepiride administered in healthy adult volunteers