Safety and pharmacokinetics study of standardized extract of Centella asiatica (ECa233) capsule in Thai healthy volunteers
- Conditions
- /AECa 233,Pharmacokinetics,Safety,Phase I
- Registration Number
- TCTR20171107002
- Lead Sponsor
- Department of Thai traditional and alternative medicine, Ministry of Public Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
1.Subjects who are Thai male or female, aged 18 to 50 years (inclusive).
2 Subjects whose BMI is 18 - 25 kg/m2
3 Subjects who are healthy by medical history, physical examination and vital signs.
4 Subject whose screening visit laboratory values of blood tests including complete
blood count, fasting blood sugar, blood urea nitrogen, serum creatinine, alkaline
phosphatase, ALT, AST, total bilirubin, albumin, total cholesterol, triglycerides, HDL
cholesterol, electrolytes, Hepatitis Bs-antigen and anti-HIV are within the normal range
or showing no clinically significant abnormalities as confirmed by the clinical
investigator.
5 For female subjects:
Female subject who is in childbearing potential must have serum β-HCG negative and
agrees to use an acceptable birth control method from visit 1 to the last visit. The
acceptable birth control method is defined as a barrier method of contraception
(including condoms, intrauterine device (IUD) and diaphragm with spermicial agent) or
total abstinence from sexual intercourse from visit 1 to the last visit. Hormonal
contraceptives are not acceptable.
Female subject who is in child bearing potential must agree not to become pregnant
for the entire participation phase and must have a negative result for urine pregnancy
test performing prior to dosing at period 1 and 2
Female subjects can be those with non-childbearing potential which defined as female
subjects with hysterectomy, both ovaries removed, surgically sterilized or
postmenopausal (for at least 12 consecutive months of amenorrhea).
6 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.
1.Subjects who are with a history/evidence of allergy or hypersensitivity to Centella asiatica or herbal substance in Apiaceae (Umbelliferae) family.
2 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 ECa233 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.
3 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 the study and until the completion of the study phase.
4 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) or subjects who are with a history of any drug abuse.
5 Subjects who receive of any medical prescription within 14 days before the first administration of ECa233, especially drug related to the study drug metabolizing enzyme and drug transporters (P-gp and MRP2).
6 Female subjects who are pregnant or breast feeding.
7 Subjects who are participating in any investigational drug study or had been in any investigational drug study within 3 months prior to the screening visit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PK parameters day1 and day 7 at 0.25, 0.5, 1, 2, 4, 8 and 24 h for period 1 and period 2 LC-MS/MS technique
- Secondary Outcome Measures
Name Time Method safety day1 observe general side effects for 8 h after drug administration and follow up until day 8 then c side effects and blood biochemical analysis:CBC, FBS, BUN, serum creatinine, alkaline phosphatase, A