A Pharmacoscintigraphy Study to Observe the Disintegration Pattern and Gastric Emptying Pattern of Vitamin B12 1500 mcg SR Oral Tablet (Containing Folic Acid, Vitamin B6, and Vitamin D3 1000 IU) Marketed by Corona Remedies Limited in 6 Healthy Adult Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- The time required for the tablet to disintegrate in the gastrointestinal tract and the location where disintegration occurs will be evaluated using Gamma Scintigraphy. The gastric residence time, which is the duration the tablet remains in the stomach, and the intestinal arrival time, when the tablet reaches the small intestine, will also be assessed. The location of the tablet at different time points will be recorded. Additional imaging at 20 and 24 hours post-dose may be performed if necessary. The time taken for the tablet to transit into the colon will be observed, and imaging may be discontinued once colon transit is achieved
研究概览
简要总结
The study titled “A Pharmacoscintigraphy Study to Observe the Disintegration Pattern and Gastric Emptying Pattern of Vitamin B12 1500 mcg SR Oral Tablet (Containing Folic Acid, Vitamin B6, and Vitamin D3 1000 IU) Marketed by Corona Remedies Limited in 6 Healthy Adult Human Subjects” is an open-label, single-arm, single-dose clinical investigation conducted to assess the disintegration and gastric emptying characteristics of a radiolabelled Vitamin B12 sustained-release tablet in healthy volunteers.
The primary objective of the study is to evaluate the disintegration pattern and gastric emptying pattern of the investigational product using 99mTc-based Gamma Scintigraphy. The secondary objective is to monitor the safety and tolerability of the study drug in healthy adults.
A total of six healthy male subjects aged between 18 to 45 years, with a Body Mass Index (BMI) of 18.5–30 kg/m² and weighing at least 50 kg, will be enrolled. Each subject will undergo thorough screening, including medical history, physical examination, and laboratory tests prior to enrollment. Subjects will be housed for at least 2 hours before dosing and for at least 12 hours post-dose, with follow-up imaging at 20 and 24 hours if required. The study duration is expected to be 8 days including screening, dosing, and follow-up.
The investigational product, a Vitamin B12 1500 mcg SR tablet (containing Folic Acid, Vitamin B6, and Vitamin D3), will be radiolabelled with Technetium-99m and administered as a single oral dose under supervision. Sequential Gamma Imaging will be conducted at multiple time points post-dose to track the tablet’s disintegration, gastric residence time, and intestinal arrival.
Safety assessments will include monitoring of vital signs, clinical examination, adverse event reporting, and laboratory tests at various time points. Additional blood samples will be collected at 2, 8, 24, 36, and 48 hours post-dose for Vitamin B12 estimation.
Strict inclusion and exclusion criteria have been defined to ensure subject safety and data integrity. Statistical analysis will be performed using appropriate software, and compensation will be provided as approved by the Institutional Ethics Committee.
The study will be conducted as per established regulatory guidelines, and the final report will be prepared upon study completion.
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).
- •The subject should be having Body Mass Index (BMI) in the range 18.5-30 kg/m2 and weighing at least 50 kg.
- •The subject must be of normal health as determined by medical history and physical examination, 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 by 60) or hypertension (BP more than 139 by
- •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 informed consent.
- •Subject with a history of known food allergy.
- •Subject who has suffered any illness or who has 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 (one unit of alcohol equal to 50 ml spirit or 200 ml wine or 500 ml beer).
- •Subject with smoking history of more than 10 Cigarettes per day or Tobacco consumption more than 4 packets per day.
- •Subject who has 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.
- •Female subjects of childbearing age or nursing women.
- •Subjects working in the radiation area or any individual who has received more than the permissible amount of radiation in the past 12 months.
结局指标
主要结局
The time required for the tablet to disintegrate in the gastrointestinal tract and the location where disintegration occurs will be evaluated using Gamma Scintigraphy. The gastric residence time, which is the duration the tablet remains in the stomach, and the intestinal arrival time, when the tablet reaches the small intestine, will also be assessed. The location of the tablet at different time points will be recorded. Additional imaging at 20 and 24 hours post-dose may be performed if necessary. The time taken for the tablet to transit into the colon will be observed, and imaging may be discontinued once colon transit is achieved
时间窗: 00.00 (within 5 minutes post-dose), 01.00, 02.00, 04.00, 06.00, and 08.00 hours post-dose
次要结局
- The incidence and severity of adverse events reported by subjects or observed by study personnel during the study will be monitored.(at throughoutthe study duration)
- Clinical examination findings, including assessments of general well-being, will be conducted(o min, 4 hours, 8 hours post-dose, and at study completion)
- Vital signs, including sitting blood pressure, pulse rate, and body temperature, will be monitored(t check-in, pre-dose, 4 hours, and 8 hours post-dose, and as needed during the study)
- Laboratory tests such as hematology, biochemistry, serology, and urine analysis will be performed at check-in and prior to end of study to detect any clinically significant abnormalities.(O mins and end of the study)
- Blood samples for estimation of Vitamin B12 levels will be collected(at 2 hours, 8 hours, 24 hours, 36 hours, and 48 hours post-dose.)
研究者
Dr Lalit Kumar Tyagi
Lloyd Institute of Management and Technology Pharm