A clinical study to observe the gastric emptying and colon targeting of Mesalamine Tablets 1200mg (Test product) of Hetero Healthcare Ltd, Hyderabad, India in 6 healthy human adult subjects.

Hetero Healthcare Ltd0 个研究点目标入组 6 人开始时间: 待定最近更新: 2022年10月17日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 6

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Pms

入排标准

入选标准

•Subject who are able to understand and ready to provide written informed consent.
•Subject must be healthy male human beings within 18-45 years of age (both inclusive).
•Subject should be having Body Mass Index (BMI) in the range 18.5-30 kg/m2 and weighing at least 50 kg.
•Subject must be of normal health as determined by medical history and physical examination, ECG and laboratory tests performed within 21 days prior to the commencement of the study.
•Subject whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.

排除标准

•Subjects must not be enrolled in the study if they meet any one of the following criteria
•Subject incapable of understanding the informed consent process or not ready to sign informed consent
•Subject with significant history of hypersensitivity to study drug or any ingredients of the formulation or any related products as well as severe hypersensitivity reactions like angioedema to any drugs
•Subject with of presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs or known to potentiate or predispose to undesired effects
•Subject with active peptic ulceration or a history of peptic ulceration
•Subject with resting hypotension Blood Pressure less than 90 by 60 or hypertension, BP more than 139 by 89
•Subject with pulse rate below than 50 per min. and above than 99 per min
•Subjects with or prior history of clinically significant, Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease
•Investigations with urine samples of subjectÃ¢â?¬•s shows clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC, more than 4HPF, Glucose (Positive) or Protein (Positive).
•Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Renal Impairment, Epilepsy, and Intracranial hemorrhage.
•Subject has inability to communicate well i.e., language problem, poor mental development, psychiatric illness, or poor cerebral function, that may impair the ability to provide, written as well as audio-video informed consent.
•Subject with a history of known food allergy.
•Subject who has suffered any illness or who have been hospitalized within the last 4 weeks preceding the start of the study.
•Subject who has taken over the counter or prescribed medications, including any enzyme modifying drugs within the last 14 days prior to the study.
•Subject with a history of drug abuse or alcoholism i.e., alcohol consumption more than 2 units per day or 10 units per week.
•Subject with smoking history of more than 10 Cigarettes per day or Tobacco consumption more than 4 packets per day.
•Subject who was participated in any other clinical trial requiring repeated blood sampling or a blood donation program or blood loss of more than 450 ml, in the past three months
•Subject with clinically significant abnormal lab values.
•Subject with positive Breath Alcohol Analysis before admission

研究者

发起方

Hetero Healthcare Ltd

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