protocolSection identificationModule nctId: NCT06324370, orgStudyIdInfo id: FIERC-2022-023, briefTitle: Exploratory Pharmacokinetic Study of Virgin Coconut Oil (VCO), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-13, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Food and Nutrition Research Institute, Philippines, class: OTHER_GOV, collaborators name: Ateneo de Manila University, collaborators name: De La Salle Medical and Health Sciences Institute, descriptionModule briefSummary: 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)., conditionsModule conditions: Pharmacological Action, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: This will be a two-sequence (single- and multiple-dose) pharmacokinetic study in healthy Filipino male human participants under fed conditions., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: This will be an open-label pharmacokinetic study in healthy Filipino male human participants under fed conditions., enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: Virgin Coconut Oil, outcomesModule primaryOutcomes measure: Pharmacokinetics (AUC0-t), primaryOutcomes measure: Pharmacokinetics (Cmax), secondaryOutcomes measure: Pharmacokinetics (AUC0-inf), secondaryOutcomes measure: Pharmacokinetics (tmax), secondaryOutcomes measure: Pharmacokinetics (Kel), secondaryOutcomes measure: Pharmacokinetics (t1/2), secondaryOutcomes measure: Vital Signs (Systolic and Diastolic Blood Pressure), secondaryOutcomes measure: Vital Signs (Pulse rate), secondaryOutcomes measure: Vital Signs (Body temperature), secondaryOutcomes measure: Vital Signs (Respiratory rate), secondaryOutcomes measure: Safety and Tolerability (Adverse events), secondaryOutcomes measure: Post Study Evaluation (Fasting Blood Sugar Test), secondaryOutcomes measure: Post Study Evaluation (Blood Urea Nitrogen Test), secondaryOutcomes measure: Post Study Evaluation (Creatinine), secondaryOutcomes measure: Post Study Evaluation (Uric Acid), secondaryOutcomes measure: Post Study Evaluation (Serum Glutamic Pyruvic Transaminase Test), secondaryOutcomes measure: Post Study Evaluation (Serum Glutamic-oxaloacetic Transaminase Test), secondaryOutcomes measure: Post Study Evaluation (Alkaline Phosphatase Test), secondaryOutcomes measure: Post Study Evaluation (TPAG- Total Protein, Albumin, Globulin Ratio Test), secondaryOutcomes measure: Post Study Evaluation (Indirect, Direct and Total Bilirubin), secondaryOutcomes measure: Post Study Evaluation (Lipid Profile - High-density lipoprotein, Low-density lipoprotein, Cholesterol and Triglycerides), secondaryOutcomes measure: Post Study Evaluation (Lipase Test), secondaryOutcomes measure: Post Study Evaluation (Amylase Test), secondaryOutcomes measure: Post Study Evaluation (Complete Blood Count with Platelet Count Test), secondaryOutcomes measure: Post Study Evaluation (Complete Urinalysis), secondaryOutcomes measure: Post Study Evaluation (Fecalysis), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI), city: Taguig, state: Metro Manila, zip: 1630, country: Philippines, geoPoint lat: 14.52429, lon: 121.07921, hasResults: False