A Multiple-Dose Research Study on Safety Evaluation of the GD Antrodia Camphorata in 30 Healthy Adult Subjects
A Multiple-Dose Research Study on Safety Evaluation of the GD Antrodia Camphorata in 30 Healthy Adult Subjects
-  Study design is multiple-dose, open-label study

 -  The purpose of this study is to evaluate the safety after twice daily GD Antrodia
 camphorata administration for 90 days in 30 healthy adult subjects.

 -  Primary objective: The mean change from baseline in laboratory assessment after
 twice daily GD Antrodia camphorata administration at 90th day in 30 healthy adult
 subjects.

 -  Secondary objective: The mean change from baseline in laboratory assessment after
 twice daily GD Antrodia camphorata administration at 10th, 20th, 30th, 45th and
 60th day in 30 healthy adult subjects.

 -  Safety Measurement:

 -  including SGOT(AST), SGPT(ALT), albumin, glucose, creatinine, uric acid,
 cholesterol, TG, r-GT, alkaline phosphatase, total bilirubin, D-Bil, BUN, TP, GLO
 will be documented at 1st, 10th, 20th, 30th, 45th, 60th and 90th day.

 -  vital signs (heart rate, blood pressure, and body temperature) will be documented
 at 1st, 10th, 20th, 30th, 45th, 60th and 90th day.

 -  Subjects will be monitored throughout the confinement portion of the study.
-  Study design is multiple-dose, open-label study

 -  Antrodia camphorata has been proved to alleviate liver injury and fibrosis induced by
 chemical and reduces ALT and AST according to the literatures.

 -  "GD Antrodia camphorata" will be marketed as dietary supplement.

 -  The purpose of this study is to evaluate the safety after twice daily GD Antrodia
 camphorata administration for 90 days in 30 healthy adult subjects.

 -  Primary objective: The mean change from baseline in laboratory assessment after
 twice daily GD Antrodia camphorata administration at 90th day in 30 healthy adult
 subjects.

 -  Secondary objective: The mean change from baseline in laboratory assessment after
 twice daily GD Antrodia camphorata administration at 10th, 20th, 30th, 45th and
 60th day in 30 healthy adult subjects.

 -  Study design is multiple-dose, open-label study

 -  The study site is Pingtung Christian Hospital Ruiguang Branch.

 -  Safety Measurement:

 -  including SGOT(AST), SGPT(ALT), albumin, glucose, creatinine, uric acid,
 cholesterol, TG, r-GT, alkaline phosphatase, total bilirubin, D-Bil, BUN, TP, GLO
 will be documented at 1st, 10th, 20th, 30th, 45th, 60th and 90th day.

 -  vital signs (heart rate, blood pressure, and body temperature) will be documented
 at 1st, 10th, 20th, 30th, 45th, 60th and 90th day.

 -  Subjects will be monitored throughout the confinement portion of the study.
Inclusion Criteria:

 -  Healthy adult, aged between 20 to 40 years old

 -  Physically and mentally healthy subjects as confirmed by an interview, medical
 history, clinical examination, laboratory tests, chest X-ray and electrocardiogram

 -  The normal range of the body mass index should between 18.5 and 24.9; body mass equals
 [weight(Kg)]/[height(m)]2

 -  Normal laboratory determinations results (within normal range or considered not
 clinically significant by the investigator) including: SGOT (AST), SGPT (ALT),
 albumin, glucose, creatinine, uric acid, cholesterol, TG, γ-GT, alkaline phosphatase,
 total bilirubin, D-Bil, BUN, TP, GLO, HBsAg and Anti-HCV.

 -  Normal hematology results (within normal range or considered not clinically
 significant by the investigator) including: hemoglobin, hematocrit, WBC count with
 differential, RBC count and platelet count.

 -  Normal urinalysis results (within normal range or considered not clinically
 significant by the investigator) including: glucose, protein, RBC, WBC, epith, casts
 and bacteria.

 -  Female subject who is using adequate contraception since last menstruation and no plan
 for conception during the study

 -  Female subject who is non-lactating

 -  Female subject who has negative pregnancy test (urine) within 14 days prior to the
 study

 -  Informed consent form signed

 Exclusion Criteria:

 -  A recent history of drug or alcohol abuse

 -  Medical history of allergic asthma or sensitivity to analogous product

 -  A clinically significant illness within the past 4 weeks.

 -  Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoetic,
 neurological, pulmonary or gastrointestinal pathology within the past 4 weeks.

 -  Ongoing peptic ulcer and constipation.

 -  Planed vaccination during the time course of the study.

 -  Participation of any clinical investigation during the last 60 days.

 -  Regular use of any medication during the last 4 weeks.

 -  Single use of any medication during the last one week.

 -  Blood donation of more than 500 mL within the past 12 weeks.

 -  Individuals are judged by the investigators or co-investigator to be undesirable as
 subjects.