Clinical Studies
PHARMACOLOGY
TOXICOLOGY
Genotoxicology Studies
Salmonella / Microsome Mutation Assay (AMES Test)
Mouse Peripheral Blood Micronucleus Assay
In Vitro Chromosome Aberration Assay in Human Peripheral Lymphocytes
Toxicology Studies
Acute oral toxicity test of Phyllanthus extract on mice
Acute toxicity test on mice by intraperitoneal administration for Phyllanthus
Acute oral toxicity test on beagle dog for Phyllanthus extract
Chronic toxicology and pharmacology of aqueous extracts of Phyllanthus urinaria in woodchucks
The 4 week repeated dose toxicity
study (oral) in rats – Phyllanthus Urinaria Extracts
PHASE II CLINICAL TRIAL
Randomized, Controlled, Phase II Clinical Trials of Hepaguard®
for the evaluation of Efficacy and Safety with Chronic Hepatitis B Patients
Trial Duration: 12 months
Trial Size: 30
During the course of treatment:
28 patients: HBV-DNA (+) > HBV-DNA (-)
7 patients: HBeAg (+) > HBeAg (-) &
Anti-HBeAb (-) > Anti-HBeAb
(+)
PHASE III CLINICAL TRIAL
Randomized, Multicenter, Double-blind, Double-dummy, Placebo-controlled Study of Hepaguard® in Patients with Chronic Hepatitis B Infection
Trial Duration:
9 months + 1 month follow-up
Trial Size:
Treatment Group - 80 patients
Comparative Group - 40 patients
Trial Completion:
May, 2002
OTC Drug License Granted:
April, 2003 (by Korea FDA)
PHASE II / III CLINICAL TRIAL
Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled Study of Hepaguard® in Patients with Chronic Hepatitis B Infection
Trial Duration: 9 months treatment + 6 months follow-up
Trial Size: 280 patients
Trial Approval Granted:
April, 2003 (by Department of Health of Taiwan, ROC)
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