Healthy
Conditions
Keywords
DLBS1033, safety, fibrinolytic, fibrinogenolytic, antiplatelet
Brief summary
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
Detailed description
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.
Interventions
DRUGDLBS1033
3 x 490 mg DLBS1033 daily
DRUGPlacebo
3 x 1 tablet daily
Sponsors
Dexa Medica Group
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female 18 - 50 year-old at screening * Having good and stable health judged on the basis of medical history, physical examination, and routine laboratory * Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study
Exclusion criteria
* Participating in other clinical trial within 4 weeks prior to screening * Had a major surgical procedure or dental procedure within 4 weeks prior to screening * History of any of the following medical conditions: haemophilia, past medical history of haemorrhagic stroke, acid peptic disease, easy bruising and frequent external bleeding * Any other known current medical condition, which is judged by the investigator could jeopardize subject's health or interfere with the study evaluation * Being on regular medication(s), including traditional medicine(s) * Pregnant or lactating women (urinary pregnancy test will be applied to women subjects during screening and just before treatment in each periods)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 14 days | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Fibrinogen level | Day 1, 2, 7, and 14 of treatment |
| Thrombin time (TT) | Day 1, 2, 7, and 14 of treatment |
| prothrombin time (PT) | Day 1, 2, 7, and 14 of treatment |
| activated-partial thromboplastin time (aPTT) | Day 1, 2, 7, and 14 of treatment |
| Number of subjects with adverse events | Day 1 and 7 of treatment |
Countries
Indonesia
Outcome results
None listed