A study to observe the movement and time required by Mesalamine tablet manufactured by Hetero Healthcare Ltd to reach colon area.
- Registration Number
- CTRI/2022/01/039171
- Lead Sponsor
- Hetero Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
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.
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 subjectââ?¬•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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the gastric emptying and colon targeting of Mesalamine Tablet 1200mg (through 99mTc based Scintigraphy for GI emptying)Timepoint: Within 05 <br/ ><br>Minutes of dosing, 02.0, 06.0, 08.0, 10.0, 12.0, 20.0 and 24.00 hrs of post dose
- Secondary Outcome Measures
Name Time Method To monitor the safety of the subjectsTimepoint: base line, during the study and end of the study (post 24hrs of drug administration)