Safety and pharmacokinetic studies of Andrographis paniculata extracts in Thai healthy volunteers
- Conditions
- Healthy volunteers with normal physical examination and vital signsScreening visit laboratory of the blood test are within the normal range.Healthy volunteersSafetyPharmacokinetics
- Registration Number
- TCTR20210201005
- Lead Sponsor
- Thailand Science Research and Innovation (TSRI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
1. Subjects who are Thai male or female, aged 18 to 55 years (inclusive).
2. Subjects whose BMI is 18 30 kg/m2 (inclusive).
3. Subjects who are negative result of COVID 19 test.
4. Subjects who are healthy by medical history, physical examination, 12 lead ECG, and vital signs.
5. whose screening visit laboratory values of blood tests including complete blood count, hematocrit, glucose, 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.
6. For female subjects:
6.1 Female subject who is in childbearing potential must have urine pregnancy test 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.
6.2 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
6.3 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).
7. 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 of COVID 19 positive test.
2. Subjects who are with a history/evidence of allergy or hypersensitivity to Andrographis paniculata.
3. 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 AP 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.
4. 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.
5. 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.
6. Subjects who receive of any medical prescription within 14 days [especially any drug related to enzyme CYP450 inducer or inhibitor: CYP1A2 (theophylline)] before the first administration of AP capsule.
7. Female subjects who are pregnant or breast feeding.
8. 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 Pharmacokinetic parameters 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 and 24 hr Non compartmental analysis will be applied to determine pharmacokinetic parameters and performed by PK solutions software (version 2.0)
- Secondary Outcome Measures
Name Time Method safety profiles Day(0-4) and Day 7 The descriptive data will be used to describe demographic characteristics and to summarize the continuous variables. Data processing will be performed using STATA software or SPSS