Biological Half Life of DLBS1033 in Healthy Volunteers

Study Overview
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Brief Summary
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DLBS1033 is bioactive protein fraction which extracted from Lumbricus rubellus earthworm. This earthworm comes from Pengalengan, West Java, Indonesia. DLBS1033 possesses 8 major proteins with molecular weight below 100 kDa, so its named as Lumbricus Low Molecular weight Proteins (LLP). This enzyme can be transported to the bloodstream via intestinal epitel. As a drug that consists of serin protease enzyme, suspected that the mechanism of action of lumbrokinase, especially as fibrinolytic and antithrombotic. One study of DLBS1033 concluded that plasmin-antiplasmin (PAP) complex is a sensitive parameter for evaluating fibrinolytic effect of this drug. But, until now there is no clinical study that evaluate pharmacokinetic of this drug. As a pilot study, the aim of this study is to evaluate biological half life of DLBS1033.

Official Title
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Biological Half Life of DLBS1033 in Healthy Volunteers

Conditions
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Healthy Condition

Intervention / Treatment
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* Drug: DLBS1033


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male 18-55 years old Body mass index between 18-25 kg/m2 Normal physical examination Patient still have the ability to undergo examinations and give written informed consent Plasmin-antiplasmin complex (PAP complex) level between 0-514 ng/ml Exclusion Criteria: Patient with cardiovascular disease, hypertension, diabetes mellitus, and dyslipidemia Creatinin serum more than 1,5 x ULN SGOT and SGPT more than 3 x ULN Blood pressure ≥ 140/90 mmHg Fasting blood glucose > 126 mg/dL Alcohol patients Took any medications (including traditional medicine, supplement and vitamin) in 1 week before the study) Patient has bleeding history which unclear etiology Hemoglobin < 10 g/dL Thrombocyte count < 100.000/microliter Heavy smoker (Bringman Index > 600)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study was open label-single arm trial, which was done at Pharmacology and Therapeutic Department and Clinical Pathologic Department of Faculty Medicine of University of Indonesia Cipto Mangunkusumo Hospital. The study drug was enteric coated DLBS1033 tablet, which contained 490 mg bioactive protein fraction; and produced by PT Dexa Medica, Tangerang, Indonesia.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single dose DLBS1033<br>Before taking the drug, blood samples will be collected from subject to assess PAP complex level, serum creatinine, SGOT, SGPT, PT and aPTT. After that, subjects will instructed to take three tablets enteric coated of DLBS1033 in front of investigator. After take the medicine blood sample will be collected on 30 minute, 60 minute, 90 minute, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour to evaluate serial PAP complex. Subjects will undergo a clinical assessment including vital signs and the presence of adverse events at the time of blood sampling. On this trial, subjects are only permitted to eat food from investigator. | Drug: DLBS1033<br> <br> |
| Experimental: steady state of DLBS1033<br>On day 1 blood samples will be collected to assess PAP complex level, serum creatinine, SGOT, SGPT, PT and aPTT. After that, subjects will instructed to take one tablet of DLBS1033 in front of investigator. Study drug packages (that consist of 8 tablets) will dispense to the subjects at day-1 and instructed to take the drug 3 times daily 30 minutes before meals. Subjects also will instructed to record any adverse events and concomitant medication prescribed in diary card. Subjects have to take the drug on 3 days (day 1, 2, and 3). On day 4, blood sample will be collected on 0 minutes, 30 minute, 60 minute, 90 minute, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour to evaluate serial PAP complex. Subjects will undergo a clinical assessment including vital signs and the presence of adverse events at the time of blood sampling. On this trial, subjects are only permitted to eat food from investigator. | Drug: DLBS1033<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serial Plasmin-antiplasmin complex (PAP complex) | PAP complex will be measured on 0 minute, 30 minute, 60 minute, 90 minute, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour | 3 days |