None listed
Conditions
Interventions
Intervention1: Vegaz OD Tablet: On schedule study day, subjects will receive a single oral dose of the radiolabelled investigational tablet with 240 mL of water.
Control Intervention1: Mesahenz Table
Sponsors
Lloyd Institute of Management & Technology
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 tabletTimepoint: 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
| Measure | Time frame |
|---|---|
| The safety and tolerability of the investigational products will be monitored throughout the study, with vital signs (blood pressure, pulse rate, and body temperature)Timepoint: 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 testsTimepoint: 4.0, 8.0, 12.0 hours and as needed | — |
Countries
India
Contacts
Public ContactDr Anjana Sharma
Lloyd Institute of Management and Technology Pharm
Outcome results
None listed