None listed
Conditions
Interventions
Intervention1: Ticagrelor 180mg Extended Release Tablet: Extended release Tablet
Intervention2: Ticagrelor Extended Release Tablet: Ticagrelor 180mg Extended Release tablet will be administered once i
Sponsors
Dr Dhaval Shah
Eligibility
Inclusion criteria
Inclusion criteria: Volunteers must meet all of the following criteria in order to be included in the study: 1. Sex: male 2. Age: 18 - 45 years (inclusive both) 3. Volunteer with BMI of 18.5-27 kg/m2 (inclusive both) with minimum weight of 50 kg. 4. Volunteer willing to provide written informed consent. 5. Non-smokers or smoker who smokes less than 10 cigarettes per day.
Exclusion criteria
Exclusion criteria: The volunteers will be excluded from the study based on the following criteria: 1. Inability to communicate or co-operate. 2. Volunteers suffering from any chronic illness such as arthritis, asthma etc. 3. History of pre-existing bleeding disorder. 4. Clinically significant abnormalities in the results of the laboratory screening evaluation. 5. Clinically significant abnormal ECG or Chest X-ray. 6. HIV, HCV, HbsAg positive volunteers. 7. History of significant blood loss due to any reason, including blood donation in the past 3 months. 8. Participation in any study within past 3 months 9. History of alcohol or drug abuse 10. History of consumption of prescribed medication since last 14 days or OTC medication/ herbal remedies since last 7 days before beginning of the study. 11. Volunteer found to be positive for alcohol test. 12. Volunteer found to be positive for opiates, tetrahydrocannabinol, amphetamine, barbiturates, benzodiazepines, cocaine based on urine test for drugs of abuse. 13. Systolic blood pressure less than 100 mmHg or more than 139 mmHg and diastolic blood pressure less than 60 mmHg or more than 89 mmHg. 14. Pulse rate less than 60/minute or more than 100/minute. 15. body temperature less than 95Ã?°F or more than 98.9Ã?°F. 16. Respiratory rate less than 10/minute or more than 20/minute. 17. History of allergy to the investigational product or any drug chemically similar to the drug under investigation. 18. Recent History of kidney or liver dysfunction. 19. Volunteers suffering from any psychiatric or neurological (acute or chronic) disorder. 20. Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers In case of marked deviations of health status leading to volunteerââ?¬•s non-inclusion in the study, wherever possible the volunteer will be explained about the same with recommendation to visit the physician for further management.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) To compare the rate and extent of absorption of Ticagrelor 180 mg Extended-release Tablet (Test 1 and Test 2, Torrent Pharmaceuticals Ltd., India) versus BRILINTAÃ?® Immediate Release Tablet containing Ticagrelor 90 mg (Reference, AstraZeneca Pharma India Ltd.) in Healthy male Volunteers under Fasting Condition. 2) To assess intra subject variability of Ticagrelor 180 mg Extended-release Tablet. 3) To optimize sampling time-points. Timepoint: Pre-dose and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 12.50, 13.00, 13.50, 14.00, 14.50, 15.00, 15.50, 16.00, 17.00, 18.00, 19.00, 20.00, 21.00, 22.00, 23.00 and 24.00 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of Ticagrelor 180 mg Extended-release Tablet in healthy male volunteers.Timepoint: Post study Period 3 | — |
Countries
India
Contacts
Public ContactDr Abhishek Shah MBBS
Torrent Pharmaceuticals Ltd., India
Outcome results
None listed