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:

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.