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CTRI Number  CTRI/2025/09/095264 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 07/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A Study Using Imaging to observe How Mesalamine Tablets pass Through the our Digestive System and Break Down in the Colon. 
Scientific Title of Study   Comparative In Vivo Gamma Scintigraphy Study of Mesalamine Tablets to assess Colon Coverage 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
LYD-2025-01, Version no -1.0 Date 20-Jul-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjana Sharma 
Designation  Principal Investigator 
Affiliation  Lloyd Institute of Management and Technology Pharm 
Address  Professor Department of Pharmacy
Plot No. 11, Knowledge Park 2 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  987381678  
Fax    
Email  sharma.anjana2003@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anjana Sharma 
Designation  Principal Investigator 
Affiliation  Lloyd Institute of Management and Technology Pharm 
Address  Professor Department of Pharmacy
Plot No. 11, Knowledge Park 2 Greater Noida

UTTAR PRADESH
201306
India 
Phone  987381678  
Fax    
Email  sharma.anjana2003@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anjana Sharma 
Designation  Principal Investigator 
Affiliation  Lloyd Institute of Management and Technology Pharm 
Address  Professor Department of Pharmacy
Plot No. 11, Knowledge Park 2 Greater Noida

UTTAR PRADESH
201306
India 
Phone  987381678  
Fax    
Email  sharma.anjana2003@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Lloyd Institute of Management & Technology 
Address  Plot No. 3, Knowledge Park II, Greater Noida, Uttar Pradesh 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anjana Sharma  Department of Pharmacy   Lloyd Institute of Engineering & Technology Room no 1, Principal office, Ground Floor Plot No. 3, Knowledge Park II, Greater Noida, Uttar Pradesh 201306
Gautam Buddha Nagar
UTTAR PRADESH 		 987381678

sharma.anjana2003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Good Society For Ethical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adult male and female participanjts  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mesacol Tablet  On scheduled study day, subjects will receive a single oral dose of the radiolabelled investigational tablet with 240 mL of water 
Comparator Agent  Mesahenz Tablet  On scheduled study day, subjects will receive a single oral dose of the radiolabelled investigational tablet with 240 mL of water. 
Comparator Agent  Rowasa Tablet  On scheduled study day, subjects will receive a single oral dose of the radiolabelled investigational tablet with 240 mL of water 
Intervention  Vegaz OD Tablet  On schedule study day, subjects will receive a single oral dose of the radiolabelled investigational tablet with 240 mL of water. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  i. Subject who are able to understand and ready to provide written informed consent.
ii. Subject must be healthy male human beings within 18-45 years of age (both inclusive).
iii. Subject should be having Body Mass Index (BMI) in the range 18.5-30 kg/m2 and weighing at least 50 kg.
iv. 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.
v. Subject whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance
 
 
ExclusionCriteria 
Details  i. Subject incapable of understanding the informed consent process or not ready to sign informed consent.
ii. 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.
iii. 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.
iv. Subject with active peptic ulceration or a history of peptic ulceration.
v. Subject with resting hypotension (BP less than 90 /60) or hypertension (BP more than 139 /89).
vi. Subject with Pulse rate below 50 per min. and above 99 per min.
vii. Subjects with or prior history of clinically significant, Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
viii. Investigations with urine samples of subject’s shows clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC, more than 4HPF, Glucose (Positive) or Protein (Positive).
ix. Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage.
x. 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.
xi. Subject with a history of known food allergy.
xii. Subject who have suffered any illness or who have been hospitalized within the last 4 weeks preceding the start of the study.
xiii. Subject who have taken over the counter or prescribed medications, including any enzyme modifying drugs within the last 14 days prior to the study.
xiv. Subject with a history of drug abuse or alcoholism i.e. alcohol consumption more than 2 units per day or 10 units per week (one unit of alcohol equal to 50 ml spirit or 200 ml wine or 500ml beer).
xv. Subject with smoking history of more than 10 Cigarettes per day or Tobacco consumption more than 4 packets per day.
xvi. 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 (approx. 90 days) (This 450 mL includes the total blood loss that will occur during the study).
xvii. Subject with clinically significant abnormal lab values.
xviii. Subject with positive Breath Alcohol Analysis before admission.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The transit time and colon arrival time of the radiolabelled Mesalamine tablets (Vegaz OD and three comparator products) will be evaluated using 99mTc-based Gamma Scintigraphy at various time points

Gastric residence time, intestinal arrival time, and rate of erosion of the radiolabelled tablet 		 5 mis, 01.0, 02.0, 03.0, 04.0, 06.0, 08.0, 10.0, 11.0, 12.0, and 24.0 hours post dosing 
 
Secondary Outcome  
Outcome  TimePoints 
The safety and tolerability of the investigational products will be monitored throughout the study, with vital signs (blood pressure, pulse rate, and body temperature)  at base line, 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, and 24.0 hours post-dose 
Adverse events will be recorded at screening, pre-dose, during dosing, and at scheduled time points post-dose, along with clinical examinations and laboratory tests  4.0, 8.0, 12.0 hours and as needed 
 
Target Sample Size   Total Sample Size="8"
Sample Size from India="8" 
Final Enrollment numbers achieved (Total)= "8"
Final Enrollment numbers achieved (India)="8" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2025 
Date of Study Completion (India) 24/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 24/11/2025 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a comparative investigator-initiated study conducted to evaluate and compare the gastrointestinal transit and colon coverage of four Mesalamine extended-release tablets in healthy adult male subjects under fasting conditions. The investigational products include Vegaz OD (Dr. Reddy’s Laboratories Limited, India), Mesahenz (La Renon Healthcare Pvt. Ltd., India), Mesacol (Sun Pharmaceutical Industries Ltd., India), and Rowasa (Meda Pharmaceuticals Inc., USA), all with a strength of 1200 mg.

A total of eight healthy adult male subjects will be enrolled and each subject will receive all four products in separate study periods, with a 15-day washout period between each administration. On each study day, a single dose of the radiolabelled tablet (labelled with Technetium-99m) will be administered with 240 mL of water under supervision, ensuring compliance and proper swallowing. Gamma scintigraphy imaging will be performed at predefined time points (within 5 minutes of dosing, and at 1, 2, 3, 4, 6, 8, 10, 11, 12, and 24 hours post-dose) to assess the tablet’s location, gastric residence time, intestinal arrival time, colon arrival time, and rate of erosion throughout the gastrointestinal tract.

Subjects will be housed from at least 2 hours before dosing until at least 12 hours after dosing, with the possibility of recall for 24-hour imaging if colon transit is not confirmed by 12 hours. Safety assessments including vital signs, clinical examinations, laboratory tests, and adverse event monitoring will be conducted throughout the study period. The expected clinical duration of the study is approximately 21 weeks from the day of check-in.

hence,study aims to provide comprehensive data on the performance of Mesalamine extended-release tablets in terms of their transit and targeting to the colon for above mentioned four different marketed tablet, supporting optimized formulation strategies and improved therapeutic outcomes.

 
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