The objective of this study are: 1. To evaluate the safety of DLBS1033 in comparison with placebo in healthy adult subject 2. To evaluate the efficacy of DLBS1033 in comparison with placebo in healthy adult subject
This study is a 2-arm, randomized, double-blind, placebo controlled, cross-over study with a fixed dose regimen. The study will involve twenty (20) healthy subjects. The study will be a comparative study of safety and efficacy of DLBS1033 with placebo. Each study period will consist of 14 days treatment with a 2-week wash-out period in between. The evaluation of safety parameters will be performed at Day 1 (baseline), 7, and 14; while the efficacy parameters will be performed at Day 1, 2, 7, and 14.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
PT Equilab International
Jakarta, Jakarta Special Capital Region, Indonesia
Safety
routine hematology (Hb, Ht, RBC, WBC, Platelet), erythrocyte sedimentation rate (ESR), liver function (ALT, AST, Gamma-GT, alkaline phosphatase), renal function (ureum, creatinine), lipid profile (total cholesterol, triglyceride, LDL-C, HDL-C), fasting blood glucose, routine urine parameters (glucose, bilirubin, ketones, specific gravity, blood, urinary pH, proteins, urobilinogen, nitrites, leucocyte esterase, and urine sediment), stool occult blood, ECG examination, clinical / physical examination
Time frame: 14 days
Fibrinogen level
Time frame: Day 1, 2, 7, and 14 of treatment
Thrombin time (TT)
Time frame: Day 1, 2, 7, and 14 of treatment
prothrombin time (PT)
Time frame: Day 1, 2, 7, and 14 of treatment
activated-partial thromboplastin time (aPTT)
Time frame: Day 1, 2, 7, and 14 of treatment
Number of subjects with adverse events
Time frame: Day 1 and 7 of treatment
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