Exploratory Pharmacokinetic Study of Virgin Coconut Oil (VCO)

Exclusion Criteria

• •history of allergy and/or sensitivity to virgin coconut oil, any of its constituents, or related drugs
• •positive Coronavirus Disease (COVID-19) Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test
• •history of anaphylaxis or angioedema
• •systolic Blood Pressure (BP) of less than 90 mm Hg and/or diastolic BP of less than 60 mm Hg
• •pulse rate of less than 50 beats/minute
• •body weight +/-15% optimum weight as related to height and body frame
• •history of tuberculosis or use of anti-tuberculosis drugs within 6 months prior to entry into study clinically significant gastrointestinal, cardiovascular, renal, hepatic, endocrine, metabolic, neurologic, psychiatric, hematological or other abnormalities, as judged by the Investigator
• •history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including torsades de pointes
• •gastrointestinal disorders which may impair drug absorption, or other conditions which could modify the absorption of the study drug, as judged by the Investigator clinically significant deviation in the clinical chemistries (liver and renal function tests) and hematology at visit 1 which may impair assessment, as judged by the Investigator
• •positive pre-study urine drug screen
• •positive/reactive Hepatitis B and human immunodeficiency virus (HIV)
• •use of any prescription drug within 30 days or any over-the-counter (OTC) drug within 14 days prior to and during the study inaccessibility of veins in left and right arm donation of blood (one unit or 350 mL) within 3 months prior to receiving the first dose of study medication
• •subjects who cannot abstain from grapefruit, citrus fruits and food and/or beverages that contain caffeine or other xanthines
• •an unusual diet, for whatever reason, e.g., low sodium diet, for two weeks prior to receiving any medication and throughout subject's participation in the study current smoker or smoking within two months prior to study enrollment
• •consumption of alcohol for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study (one drink is equal to one unit of alcohol - one glass wine, half pint beer, and one measure/one ounce of spirit)
• •participation in a clinical study within 3 months prior to visit 1
• •significant illness during the 4 weeks preceding screening of the study
• •having an occupation or requirement of driving a vehicle or operate a complex machinery before 21 days of taking the drug in both periods