| Eligibility |
Inclusion Criteria:
- Healthy male aged 18 to 55 years inclusive.
- Subjects with a body mass index from 18.5 to 30.0 kg/m2.
- Subjects who are healthy as determined by routine physical examination, including
vital sign monitoring (i.e., blood pressure, heart rate, and temperature), 12-lead ECG
and laboratory analysis (i.e., hematology, blood biochemistry, Serology and
urinalysis), or as determined by the investigator.
- Subjects should have negative urine test for drugs of abuse (Opiates and cannabinoids
will be tested) and negative result for alcohol breath test at screening and prior to
each check-in
- Tested negative for COVID-19 (through COVID-19 antibody testing).
- Subjects and their partners are willing to use reliable non-hormonal contraceptive
methods (condoms, diaphragm, non-hormonal intra-uterine device (IUD), female or male
sterilization or sexual abstinence) throughout the study and up to 30 days after the
last administration of the study drug.
- All subjects should be free from any epidemic or contagious disease (e.g. Malaria,
Dengue, COVID-19).
- Subjects are able to, understand and sign the Informed Consent Form for Medical
Screening during their screening visit and Participation Informed Consent Form on
study Check-In day
- Subject agreed not to consume food or beverages like tea, coffee, cola drinks,
chocolates containing Xanthene derivatives (including caffeine, theobromines, etc.)
and/or poppy seeds (Khashkhash) within 48-hours prior to drug administration until
last blood draw in each study period.
- Subject agreed not to intake prescription medicine within 14 days or 5 half-lives
(whichever is longer) prior to first dose of study medicine.
- Subject agreed not to intake non-prescription drugs (OTC such as aspirin, ibuprofen,
naproxen, non-steroidal anti-inflammatory drugs (NSAIDs), or any other drug known to
increase the tendency for bleeding within 14 days prior to first dose of study
medicine.
- Subject agreed to discontinue vitamins, dietary and herbal supplements within 14 days
prior to the first dose of study medication.
- Subject agreed not to consume grapefruit and/or its products within 14 days prior to
the start of study.
Exclusion Criteria:
- Refused to sign Informed Consent Form.
- Inability to take oral medication.
- Tested positive for COVID-19 (through COVID-19 antibody testing).
- History of smoking (> 5 cigarette/day), alcoholism, and positive test for drug of
abuse.
- Heavy pan or gutka user as judged by teeth/mouth inspection.
- Subjects with clinically relevant evidence of cardiovascular,
gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital,
hematologic/immunologic, HEENT (head, ears, eyes, nose, throat),
dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug
hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as
revealed by medical history, physical examination, and laboratory assessments which
may interfere with the absorption, distribution, metabolism or elimination of drugs or
constitute a risk factor when taking study medication.
- Donation or loss of more than 450 mL of blood within 3 months prior to the screening.
- History of intake of any prescribed medicine during a period of 30 days, prior to drug
administration day of study.
- Subject is allergic to Ticagrelor and/or other antiplatelet medications/platelet
aggregation inhibitors.
- Subject has received any investigational drug within four weeks prior to screening.
- Subjects whose heart rate is abnormally low (usually lower than 60 beats per minute)
and subject already have in place a device that paces the heart (pacemaker).
- Subjects with a history of hemophilia, von Willebrand's disease, lupus anticoagulant,
or other diseases/syndromes that can either alter or increase the propensity for
bleeding.
- A personal history of vascular abnormalities including aneurysms; a personal history
of severe hemorrhage, non-traumatic bleeding, bleeding risks, hematemesis, melena,
hemoptysis, severe epistaxis, severe thrombocytopenia, intracranial hemorrhage; or
rectal bleeding within 1 year prior to screening; or history suggestive of peptic
ulcer disease; or at the discretion of the investigator.
- Platelet count is less than 150 x 10^9/L.
- Subject has had a blood test that showed more than the usual amount of uric acid.
- Subjects receiving oral anticoagulants often referred to as "blood thinners" which
include warfarin.
- History of any significant illness in the last four weeks .
- Consumption of grapefruit and/or its products within 14 days prior to the start of
study.
- Subjects who test positive for syphilis (VDRL) or who are known to have serum
hepatitis or who are carriers of the Hepatitis B surface antigen (HBs Ag) or are
carriers of antibodies to hepatitis C virus (anti-HCV), human immunodeficiency virus
(HIV-1 or HIV-2) or COVID-19.
- Individuals having undergone any major surgery (including dental work) within 3 months
prior to the start of the study, unless deemed eligible, otherwise by the Principal
Investigator or whomever he/she may designate.
- Subject has a history of any illness that, in the opinion of investigator might
confound the result of the study or pose any risk in administrating Ticagrelor to the
subject.
- Subjects with any condition, which, in the opinion of the Investigator, may interfere
with the absorption, distribution, metabolism or elimination of drugs.
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