None listed
Conditions
Interventions
Intervention1: Vitamin B12 1500 mcg SR Oral Tablet: A single oral dose of Vitamin B12 1500 mcg SR Tablet labeled with Technetium 99mTc will be administered once on the dosing day with 240 ml of water
Sponsors
Corona Remedies Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion 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 (BP less than 90 by 60) or hypertension (BP more than 139 by 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 achievedTimepoint: 00.00 (within 5 minutes post-dose), 01.00, 02.00, 04.00, 06.00, and 08.00 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events reported by subjects or observed by study personnel during the study will be monitored.Timepoint: at throughoutthe study duration;Clinical examination findings, including assessments of general well-being, will be conductedTimepoint: 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 monitoredTimepoint: 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.Timepoint: O mins and end of the study;Blood samples for estimation of Vitamin B12 levels will be collectedTimepoint: at 2 hours, 8 hours, 24 hours, 36 hours, and 48 hours post-dose. | — |
Countries
India
Contacts
Public ContactDr Lalit Kumar Tyagi
Lloyd Institute of Management and Technology Pharm
Outcome results
None listed