Healthy Thai adults Healthy, Adults
Conditions
Interventions
Each IP dose will consist of two 300 mg ROSMARICA capsules taken with 240 mL of drinking water. A total of seven consecutive doses will be administered each 8 hours apart.
Experimental Other
ROSMARICA capsules
Sponsors
K Agro-innovate Institute
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Participant is a 18 to 45 years old Thai male or female. 2) Participant has a BMI between 18.0 to 30.0 kg per m2. 3) Participant is healthy, as determined by physical examination, medical history, and vital signs (blood pressure (systolic between 90-139 mmHg, diastolic between 60 to 89 mmHg), body temperature, pulse rate, respiratory rate) and displays no clinically significant abnormalities as evaluated by the Principal or Sub Investigator. 4) Participant has normal or acceptable results (no clinically significant abnormalities) for CBC with differential, FBS, BUN, Cr, CrCl, AST or SGOT, ALT or SGPT, ALP, total bilirubin, and urinalysis as evaluated by the Principal or Sub Investigator. 5) Participant has a negative result for HBsAg. 6) Participant has a normal or acceptable EKG (no clinically significant abnormalities) as evaluated by the Principal or Sub Investigator. 7) Female participant who has a negative urine pregnancy result at screening and agrees not to become pregnant for the entire participation period. 8) Female participant of childbearing potential or male participant who agrees to use effective non-hormonal contraceptive methods (e.g., condoms, diaphragms, cervical caps) or abstain from sexual intercourse since the screening visit until the end of the participation period. 9) Female participant of non-childbearing potential (i.e., hysterectomy, bilateral oophorectomy, surgically sterilized, or postmenopausal at least 12 consecutive months of amenorrhea). 10) Participant is a non-smoker (never smoked or has not smoked for at least 1 year). 11) Participant has not used herbal medications, cannabis containing products, dietary supplements (e.g., St. Johns Wort, Ginkgo biloba, garlic supplements), vitamins, grapefruit or grapefruit juice, or pomelo within 14 days of Day 1. 12) Participant ended the use of systematic medications at least 30 days from Day 1 and agrees to continue refraining from using them throughout the participation period. 13) Participant agrees to refrain from consuming caffeinated and alcoholic products for at least 72 hrs before Day 1 and agrees to continue refraining from consuming them throughout the participation period. 14) Participant agrees to comply with the requirements of study and is available throughout the study period. 15) Participant is willing to participate in the study and can comprehend the contents of, as well as sign, the informed consent form before study participation.
Exclusion criteria
Exclusion criteria: 1) Participant has a known hypersensitivity to the IP, its constituents, and or related chemical compounds. 2) Participant has a history, or concurrent symptoms of, cardiovascular, gastrointestinal, or hematologic disorders renal and hepatic impairment and or any disease that may affect the IPs bioavailability. 3) Participant abuses or excessively consumes (more than 1 time per week) alcoholic products within the last 12 months. 4) Participants alcohol breath test displays a blood alcohol concentration more than 0.000 percentage at screening or before admission. 5) Participant has a history of drug abuse or their urine sample tests positive for morphine, tetrahydrocannabinol, or methamphetamine at visit or before admission. 6) Participant is pregnant (positive urine pregnancy test at screening or before admission) or breastfeeding. 7) Participant is a woman of childbearing potential using hormonal contraceptive methods (i.e., oral contraceptives, hormone replacement therapy, or transdermal contraceptives) within 14 days of the first IP dose plans to use hormonal contraceptive methods throughout the study period or using injected, intrauterine, and implanted hormonal methods of contraception within 3 months of the first IP dose or plans to use such methods throughout the study period. 8) Participant was enrolled in an IP study within 30 days of Day 1 (counted from the last visit of that study that the patient received IP to the screening visit of this study). 9) Participant has donated blood or suffered from massive blood loss within 2 months of Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Rosmarinic acid concentrations Day-14to-1, Day10 liquid chromatography tandem mass spectrometry (LC-MS/MS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety all times adverse event report | — |
Countries
Thailand
Contacts
Public ContactSuvimol Niyomnaitham
Siriraj Hospital Mahidol University
Outcome results
None listed