| Eligibility |
Inclusion Criteria:
- Healthy subjects aged 18 to 55 years inclusive.
- Subjects with a body mass index (BMI) from 18.5 to 30 kg/m2.
- Subject is able to fast for 14 hours and consume standard meals.
- 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 safety laboratory analysis (i.e., hematology, blood biochemistry, and
urinalysis) or viral serology as determined by the investigator.
- Subjects should have negative urine test for drugs of abuse (morphine & cannabinoids
will be tested) and alcohol breath analysis at screening and prior to each check-in.
- Subjects who 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 including tea, coffee, cola drinks,
chocolates containing xanthine derivatives (including caffeine, theobromines, etc.)
and/or poppy seeds (Khash khash) within 48 hours prior to drug administration until
last blood draw in each study period.
- Subject agreed not to intake prescription drugs (especially any other PPI,
Antiretroviral (e.g. rilpivirine, atazanavir and nelfinavir), Warfarin, clopidogrel,
methotrexate, drugs dependent on gastric pH for absorption, etc.) 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) 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:
- Subjects who refused to sign Informed Consent Form.
- Inability to take oral medication.
- Pregnant and lactating females.
- History of smoking =3 cigarette/day, alcoholism, and positive test for drug of abuse,
heavy pan or gutka user as judged by teeth / mouth inspection.
- Subject has clinically relevant evidence of cardiovascular, gastrointestinal/hepatic,
renal, psychiatric, respiratory, urogenital, hematological/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.
- Subjects allergic to Dexlansoprazole and/or other Antacid drugs.
- Subject has received any investigational drug within four weeks.
- Participated in any clinical trials within 3 months.
- Donation or loss of more than 450 mL of blood within 3 months prior to the screening.
- History of any significant illness in the last four weeks which might confound in the
result of the study or post additional risk in administrating Dexlansoprazole to the
subject.
- Subjects tested positive for syphilis (VDRL) or is known to have serum hepatitis or
carrier of the Hepatitis B surface antigen (HBs Ag) or are carriers of antibodies to
hepatitis C virus (anti-HCV) or to the human immunodeficiency virus (HIV-1 or HIV-2).
- Subject tested positive for COVID-19 or is known to have such family members who
tested positive for COVID-19 in recent times.
- Subject has undergone any major surgery 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 condition, which, in the opinion of the Investigator, may interfere with
the absorption, distribution, metabolism or elimination of drugs.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- History of asthma, anaphylaxis or anaphylactic reactions, severe allergic responses.
- A heart rhythm disorder (especially if you take medication to treat it) or history of
long QT syndrome.
|
