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

SRM College of Pharmacy SRM Institute of Science and Technology0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•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

•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

发起方

SRM College of Pharmacy SRM Institute of Science and Technology