Healthy volunteers with normal physical examinations, vital signs, and screening laboratory blood test results within the normal range. Healthy volunteers, Safety, Pharmacokinetics, Ginger
Conditions
Interventions
Tested product: Commercially available ginger crude powder capsule.
Detail: Single oral administration.
Dose: Group 1 receive capsule A (before meal), with a dosage of 8 capsules.
,Tested product: Co
8 capsules,16 capsules
Sponsors
Thailand Science Research and Innovation (TSRI)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1 Subjects who are Thai male or female, aged 18 to 55 years (inclusive). 2 Subjects whose BMI is 18.0-30.0 kg/m2 (inclusive). 3 Subjects who have not a high risk for Coronavirus infection and are negative result of COVID-19 test kit 5 Subjects who are healthy by medical history, physical examination, blood chemistry, and vital signs. 6 Subject whose screening visit laboratory values of blood tests including complete blood count, glucose, blood urea nitrogen, serum creatinine, alkaline phosphatase, ALT, AST, total bilirubin, albumin, total cholesterol, triglycerides, HDL cholesterol, and electrolytes, are within the normal range or showing no clinically significant abnormalities as confirmed by the clinical investigator. 7 Female subject who is in child bearing potential must agree not to become pregnant for the entire participation phase. 8 Subjects are able to understand the requirements of the study and voluntarily sign and date an informed consent, approved by the Independent Ethic Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Exclusion criteria
Exclusion criteria: 1 Subjects who have high risk for Coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19 or positive test kit 3 Subjects who are with a history/evidence of allergy or hypersensitivity to ginger. 4 Subjects who have a history of any illness that, in the opinion of the clinical investigator, might confound the result of the study or pose an additional risk in administrating ginger capsule to the subjects. This may include but not limited to: a history of relevant drug or food allergies; history or cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements. 5 Subjects who are with a history of heavy smoking (more than 10 cigarettes per day) or moderate smoking (less than 10 cigarettes per day) and cannot omit smoking at least one day before enroll in the study and until the completion of the study phase. 6 Subjects who are with a history of alcoholic (more than 2 years) or moderate drinkers (more than 3 drinks per day (one is equal to one unit of alcohol, one glass of wine, half pine of beer or one measure of spirit) and cannot omit alcohol drinking at least 14 days before enroll in the study and until the completion of the study phase or subjects who are with a history of any drug abuse. 8 Female subjects who are pregnant or breast feeding. 9 Subjects who are participating in any investigational drug study or had been in any investigational drug study within 3 months prior to check-in in the study. 10 Subjects who have been prescribed any medications within 14 days prior to the initial administration of the investigational capsule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters Plasma: 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 and 24 hours post dose Non compartmental analysis will be applied to determine pharmacokinetic parameters and performed by PK solutions software (version 2.0),Pharmacokinetics of metabolites Urine: T 0-4, 4-8, 8-12, and 12-24 hours after dosing Non compartmental analysis will be applied to determine pharmacokinetic parameters and performed by PK solutions software (version 2.0) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety profiles day 1 (predose) and day 2 (24 h) adverse events and blood chemistry testing (liver functions: AST and ALT; renal functions: BUN, Creatine, eGFR; lipid profiles; blood glucose and CBC) | — |
Countries
Thailand
Contacts
Public ContactJutamaad Satayavivad
Chulabhorn Research Institute
Outcome results
None listed