healthy human volunteers The safety assessments will be performed,
Conditions
Interventions
comparison of different dosages of drug
All volunteers in both groups receive a single dose of TL capsules (500 mg/day of TL leaf extract) by oral administration with 240 mL of water before meals,
1 times per day for 3 consecutive days.,comparison of different dosages of drug
All volunteers in both groups receive a single dose of TL capsules (1,
000 mg/day of TL leaf extract) by oral administration with 240 mL of water before meals,
1 times per day for 3 consecutive days.
Experimental Drug,Experimental Drug
500 mg Thunbergia laurifolia Leaf Extract,1,
000 mg Thunbergia laurifolia Leaf Extract
Sponsors
-
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (a) age 18 to 45 years (b) body mass index between 18 and 25 kg/m2 (c) non-pregnant and non-lactating (d) negative screening assessment for human immunodeficiency virus or viral hepatitis (Hep B or Hep C) and HIV infection/acquired immune deficiency syndrome (e) agree to abstain from using tobacco or nicotine-containing products, consuming alcohol, grapefruit, or grapefruit juice, or taking any prescribed medicine (except mild analgesics (e.g. paracetamol) or oral contraceptives) or herbal supplement or vitamin supplement within 7 days before the study until completion of the study (f) be able to communicate effectively with study personnel (g) willing and able to comply with the study requirements (h) written informed consent obtained
Exclusion criteria
Exclusion criteria: (a) having a current acute or chronic disease (a history of cardiovascular, hepatic, renal, endocrinal, gastrointestinal, neurologic, or hemorrhagic disease (b) having a clinically important history of a medical disorder (c) having a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically important reaction to any herbal medicine (d) having received another investigational drug or been participated in an investigational drug or device study within the 30 days prior to this study (e) having a history of drug abuse within 6 months prior to screening (f) a bleeding risk, such as a recent operation or uncontrolled hypertension (g) having a history of a major operation in last 6 months (h) having substantial diseases or significant abnormalities in laboratory values (creatinine clearance, <60 mL/min), serum aspartate aminotransferase or alanine aminotransferase 41.5 times the upper limit of normal (i) failure or disagreement to use a medically acceptable contraceptive method during the study period (j) known prisoner (defined as any individual involuntarily confined or detained in a penal institution or any individual in police custody who must have a police escort at all times) (k) participant in another investigational trial during the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics profiles 2 month LC-MS/MS | — |
Secondary
| Measure | Time frame |
|---|---|
| safety 2 month physical examination and laboratory investigation | — |
Countries
Thailand
Contacts
Public ContactSophida Sukprasert
hulabhorn International College of Medicine, Thammasat University
Outcome results
None listed