Safety and Efficacy of DLBS1033 in Healthy Subjects

Study Overview
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Brief Summary
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The objective of this study are: To evaluate the safety of DLBS1033 in comparison with placebo in healthy adult subject To evaluate the efficacy of DLBS1033 in comparison with placebo in healthy adult subject

Detailed Description
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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.

Official Title
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A Randomized, Double Blind, Placebo Controlled, Cross-over, and Fixed Dose Study to Evaluate the Safety and Efficacy of DLBS1033 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: DLBS1033
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1<br>Test drug treatment: 3 x 490 mg DLBS1033 daily | Drug: DLBS1033<br>* 3 x 490 mg DLBS1033 daily<br>|
| Placebo Comparator: Treatment 2<br>Placebo treatment: 3 x 1 tablet daily | Drug: Placebo<br>* 3 x 1 tablet daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DLBS1033, safety, fibrinolytic, fibrinogenolytic, antiplatelet