A study to observe the movement and time required by Mesalamine tablet manufactured by Hetero Healthcare Ltd to reach colon area.
- Conditions
- Mesalamine is used to treat ulcerative colitis
- Registration Number
- CTRI/2022/01/039171
- Lead Sponsor
- Hetero Healthcare Ltd
- Brief Summary
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|**Objectives:**
**Primary Objective**
· To evaluate the gastric emptying and colon targeting of Mesalamine Tablet 1200mg (through 99mTc based Scintigraphy for GI emptying)
**Secondary Objective**
· To monitor the safety of the subjects.
|**Study Design:**
An open label, single arm, single dose, single-period, single-treatment, single-sequence, oral Pharmacoscintigraphy based clinical study.
|**Study population and sample size**
A sufficient number of subjects will be enrolled to ensure dosing of 6 healthy adult human subjects.
|**Housing:**
At least 2 hours prior to dosing until at least 12 hours post dose
|**Study duration****:**
Considering the minimum washout period, expected study duration of clinical part is 8 days from the day of check-in of first period.
|**Test Product:**
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|Product
Mesalamine Tablet
|Dosage Form
Extended-Release tablet
|Strength
1200 mg
|Drug Name
Mesalazine / Mesalamine (1200mg)
|Manufactured By
Hetero Healthcare Ltd Laboratories Ltd, Mumbai, India
|**Radioactive element**
Technetium Pertechnetate - 99mTcO4
|**Radiation Dose**
99mTc- labelled - Mesalamine will contain 500- 700 µCi of Technetium pertechnetate/ Tablet
|**Pre-study Screening**
Demographic Data, Medical and Medication histories, General and Systemic Physical Examination, Hematology, Biochemistry, Serology and Urine Analysis.
|**Tests at the time of Admission**
Alcohol breath test will be done at the time of admission
|**Admission and Stay**
After signing of informed consent document, a unique ID will be allotted to study subjects to maintain their identity confidential. Subject will be housed at least 2.00 hours before drug administration to 12.00 hours after drug administration and subject will be call for 20 hrs and 24.00 hrs Gamma Imaging on next day
|**Administration of Investigational products:**
A single oral dose of the investigational product (Test product) will be surface labeled with Technetium -99mTc and will be administered to the subject in a sitting posture with 240 mL of drinking water at ambient temperature on study day under supervision of trained study personnel. The clinical staff (dosing personnel) will ensure that the study subject has swallowed medication by performing mouth check using torchlight and spatula to assess compliance to dosing. Investigational products (must be swallowed whole and must not be chewed, crushed or divided.
|**Gamma Imaging Schedule**
Sequential static imaging- shall be performed at 00.00 (Within 05 Minutes of dosing), 02.0, 06.0, 08.0, 10.0, 12.0, 20.0 and 24.00 hrs post dose for two minutes. Additional images can be taken as per investigator discretion without discomfort to subject. For post dose Gamma Imaging will be performed with a window period of ± 05 Minutes.
|**Food and fluid restrictions:**
Water will be restricted from at least 01 hour prior to dosing until at least 01-hour post-dose, (except for water given with dosing).
Subjects should not consume alcohol and smoke 48 hours before drug administration and throughout study period. Subject should not consume grapefruit containing products for 48 hours before the drug administration and throughout the study.
|**Posture restrictions****:**
Subject will remain in semi recumbent position on bed for initial 08 hours post-dose and only necessary movement will be allowed during this period. Thereafter subjects will be allowed to ambulate freely during the remainder of the study.
|**Collection of blood samples:**
In this study, total 2 (10X 2 ml each) blood samples will be collected for Screening Sample and Post study safety sample.
The pre-dose blood sample for screening shall be taken within 120 minutes prior to dosing.
|**Other Samples**
Blood volume up to 10 ml and urine volume of up to 25 ml for additional or repeat clinical laboratory tests will be taken if necessary.
|**Handling of blood samples:**
After collection, the blood samples will be placed in an ice bath or other chilling device until centrifugation. Blood samples will be placed in a refrigerated centrifuge within 45 minutes of blood sample collection.
|**Safety Assessment:**
***Vital signs:***
· Sitting blood pressure, pulse rate and body temperature will be measured at the time of check-in and prior to check-out. Subjects must have vital signs clinically acceptable prior to check-in to study.
· Sitting blood pressure, pulse rate and body temperature will be measured prior to dosing and during the study.
· Sitting/supine blood pressure and pulse rate will be measured at 6.0, & 12.0 hours (± 30 minutes) post dose and as needed in study.
· Sitting blood pressure, pulse rate and body temperature will be measured at 12.0 hours (± 30 minutes) post dose in study.
Subject having sitting systolic blood pressure less than 100 mmHg or sitting diastolic blood pressure less than 60 mmHg during pre-dose will not be dosed.
***Clinical examination:***At the time of check-in and prior to check-out in study and during the study.
***Well Being assessment:***
Subjects will be advised to report any AE and will be specifically asked by trained study personnel in a non-leading manner about any AE at the time of clinical examinations, during vital signs recording, at about 6.0, & 12.0 hours post dose and as needed and during study. Necessary treatment of an AE will be performed by the Investigator or physician and recorded.
All dosed study subjects will be assessed for clinical examination including vital sign (sitting blood pressure, pulse rate and body temperature) and laboratory tests at the end of the study or as applicable
|**Analytical methodology: Parameters studied by Scintigraphy**
Parameters mentioned below will be evaluated by imaging captured by Gamma camera (99mTc based Scintigraphy)-
· Location of radiolabeled investigation product in GIT at different time interval
· Gastric residence time
· Intestinal arrival time
· Colon arrival time
· Colon residence time
|**Statistical Analysis:**
Statistical analysis will be performed on the observed parameters using suitable statistical software.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- 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 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).
- 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) Within 05 | 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 subjects base line, during the study and end of the study (post 24hrs of drug administration)
Trial Locations
- Locations (1)
Ganesh Diagnostic & Imaging Centre Pvt. Ltd
🇮🇳West, DELHI, India
Ganesh Diagnostic & Imaging Centre Pvt. Ltd🇮🇳West, DELHI, IndiaDr Ravin SharmaPrincipal investigator9212125996sharmaravin999@yahoo.com