Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Healthy subjects.
Ethnic Group: Arab & Mediterranean
Race: Mixed skin (white & black skin people).
Age 18-50 years
Body-mass index 18.5 to 30.0 kg/m2 inclusive (minimum of 50 kg weight).
Subject is available for the whole study period and gave written informed consent
Physical examination within normal ranges
All laboratory screening results within the normal range, or being assessed as clinically non-significant by the attending physician
Vital signs within normal ranges.
Kidney function test, Liver function test should be within normal ranges.
Pre dosing blood pressure more than 110/70 mmHg.

Exclusion Criteria:

Women of childbearing potential, pregnant and lactating women.
Ethnic Group (Non- Arab &/ or Non- Mediterranean)
History of severe allergy or allergic reactions to study drug or related drugs or heparin
Known history or presence of food allergies, or any surgical or medical condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
History of serious illness that can impact fate of drugs
Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the Principal Investigator, or medical designate
Clinically significant illness 4 weeks before study Period I
Serious mental disease, drug, alcohol, solvents or caffeine abuse, smoking.
Regular use of medication
Having taken medication that could affect the investigated drug product: a) Regular consumption of drugs during the two weeks prior to study initiation day, b) consumption of enzyme stimulating or inhibiting drugs (e.g. Barbiturates, Carbamazepine, Phenytoin, Amphetamine, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, and methadone) during one month before the study initiation
Presence of any significant physical or organ abnormality
Donation of 1) at least 400 ml of blood within 60 days, or 2) more than 150 ml of blood within 30 days, or 3) more than 100 ml blood plasma or platelets within 14 days before study Period I
Participation in another bioequivalence study within 80 days prior to the start of this study Period I
Following a special diet (e.g. vegetarian) or dieting one month before the study initiation.
Prior history of hypersensitivity to Amlodipine besylate, Losartan Potassium & Hydrochlorothiazide.
Consumption of grapefruit or grapefruit containing products within 7 days of drug administration
Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
Any significant clinical abnormality including HBsAg, HCV, and HIV
Abnormal vital signs.
Abnormal Kidney or Liver function tests.
Vomiting, Diarrhea.
Pre dosing blood pressure less than 110/70 mmHg
Positive test for elicit drugs and alcohol prior to dosing in each period.