None listed
Conditions
Interventions
Intervention1: Etoricoxib 60mg + Paracetamol 325mg Tablet: A single oral dose of the investigational product (Etoricoxib 60mg + Paracetamol 325mg Table) surface labeled with Technetium -99mTc will be
Sponsors
Systopic laboratories private 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). 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, 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: Subjects must not be enrolled in the study if they meet any one of the following 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 has suffered any illness or who has been hospitalized within the last 4 weeks preceding the start of the study. xiii. Subject who has 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 around 50 ml spirit or 200 ml wine or 500 ml beer). xv. Subject with smoking history of more than 10 Cigarettes per day or Tobacco consumption more than 4 packets / 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. Female subjects of childbearing age or nursing women. xix. Subjects working in 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 following parameters will be evaluated using images captured by a Gamma camera (99mTc-based Scintigraphy): Time required for the radiolabelled investigational product to disintegrate in the GIT Location of disintegration in the GIT Location of the radiolabelled investigational product in the GIT at the specified time intervals Gastric residence time Intestinal arrival timeTimepoint: Estimated by Sequential static imaging at 00.00 (Within 05 Minutes of dosing), 01:00, 02.00, 04.00, 06.00, 8.00, 10.00, and 12.00 (if required) | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the subjects through out the study duration.Timepoint: At 00.00 (Within 05 Minutes of dosing), 01:00, 02.00, 04.00, 06.00, 8.00, 10.00, and 12.00 (if required) | — |
Countries
India
Contacts
Public ContactDr Abha Mishra
Delhi Diabetes Clinic
Outcome results
None listed