CTRI/2022/01/039171
Completed
未知
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 sites6 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hetero Healthcare Ltd
- Enrollment
- 6
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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