Bioequivalence of Virgin Coconut Oil (VCO) Among Healthy Filipino Male Adults: An Exploratory Pharmacokinetic Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Pharmacokinetics (Cmax)
研究概览
简要总结
This is a balanced, open-label, single- and multiple-dose pharmacokinetic (PK) study of virgin coconut oil (VCO) among healthy Filipino male adults 18-45 years of age in Dasmariñas, Cavite. This study aims to determine the rate and extent of absorption of virgin coconut oil (VCO) administered in healthy male human study participants under fed conditions in single and multiple doses and to monitor the safety and tolerability of virgin coconut oil (VCO) following the standard protocol developed by the De La Salle Medical and Health Sciences Institute (DLSMHSI).
详细描述
Virgin coconut oil (VCO) will be administered with 240 ml water and standardized food on dosing periods, with a 5-day interval between the single-dose (0.6 ml/kg body weight) and the multiple-dose (1.2 ml/kg body weight divided into three doses daily) study periods. For the single-dose study, blood for PK analysis will be collected at pre-dose (-0.5 and 0 hours), then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 14, and 24 hour/s post-dose. For the multiple-dose study, blood samples will be collected on the last day of dosing before the 2nd dose (at -0.5 and 0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 14, and 24 hour/s post-dose. Sample collection will be continued after the last multiple dose at the following time points: 48, 72, 96, 120 and 144 hours. In addition, pre-dose blood samples will be collected daily from Day 8-12 to determine trough plasma concentrations and the approach to steady state. Blood samples will be sent to the Ateneo De Manila University (AdMU) for gas chromatography-mass spectrometry (GC-MS) analysis. Established primary and secondary endpoints for pharmacokinetics and safety and tolerability will be evaluated.
This study is necessary to establish human data on the pharmacokinetics of virgin coconut oil (VCO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
This will be an open-label pharmacokinetic study in healthy Filipino male human participants under fed conditions.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Filipino male
- •18-45 years of age
- •signed written informed consent obtained
- •body-mass index of ≥18.5 kilogram per meter-squared (kg/m2) and ≤ 24.9 kg/m2, with body weight not less than 50 kilogram(kg)
排除标准
- •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
结局指标
主要结局
Pharmacokinetics (Cmax)
时间窗: 25 days
Maximum plasma concentration
Pharmacokinetics (AUC0-t)
时间窗: 25 days
Area under the concentration-time curve from administration to the last observed concentration at time t hr
次要结局
- Pharmacokinetics (AUC0-inf)(25 days)
- Vital Signs (Pulse rate)(25 days)
- Safety and Tolerability (Adverse events)(25 days)
- Vital Signs (Respiratory rate)(25 days)
- Post Study Evaluation (Blood Urea Nitrogen Test)(25 days)
- Post Study Evaluation (TPAG- Total Protein, Albumin, Globulin Ratio Test)(25 days)
- Post Study Evaluation (Indirect, Direct and Total Bilirubin)(25 days)
- Post Study Evaluation (Complete Urinalysis)(25 days)
- Pharmacokinetics (tmax)(25 days)
- Pharmacokinetics (t1/2)(25 days)
- Vital Signs (Body temperature)(25 days)
- Pharmacokinetics (Kel)(25 days)
- Post Study Evaluation (Fasting Blood Sugar Test)(25 days)
- Post Study Evaluation (Complete Blood Count with Platelet Count Test)(25 days)
- Vital Signs (Systolic and Diastolic Blood Pressure)(25 days)
- Post Study Evaluation (Alkaline Phosphatase Test)(25 days)
- Post Study Evaluation (Lipid Profile - High-density lipoprotein, Low-density lipoprotein, Cholesterol and Triglycerides)(25 days)
- Post Study Evaluation (Creatinine)(25 days)
- Post Study Evaluation (Serum Glutamic Pyruvic Transaminase Test)(25 days)
- Post Study Evaluation (Lipase Test)(25 days)
- Post Study Evaluation (Fecalysis)(25 days)
- Post Study Evaluation (Uric Acid)(25 days)
- Post Study Evaluation (Serum Glutamic-oxaloacetic Transaminase Test)(25 days)
- Post Study Evaluation (Amylase Test)(25 days)
研究者
Carl Vincent D. Cabanilla
Senior Science Research Specialist
Food and Nutrition Research Institute, Philippines