Comparative In Vivo Gamma Scintigraphy Study of Mesalamine Tablets to assess Colon Coverage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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 (BP less than 90 /60) or hypertension (BP more than 139 /89).
- •Subject with Pulse rate below 50 per min.
- •and above 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 have suffered any illness or who have been hospitalized within the last 4 weeks preceding the start of the study.
- •Subject who have 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 (one unit of alcohol equal to 50 ml spirit or 200 ml wine or 500ml beer).
- •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 (approx.
- •90 days) (This 450 mL includes the total blood loss that will occur during the study).
- •Subject with clinically significant abnormal lab values.
- •Subject with positive Breath Alcohol Analysis before admission.
结局指标
主要结局
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
时间窗: 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
Gastric residence time, intestinal arrival time, and rate of erosion of the radiolabelled tablet
时间窗: 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
次要结局
- 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)
研究者
Dr Anjana Sharma
Lloyd Institute of Management and Technology Pharm