Healthy Condition
Conditions
Brief summary
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.
Interventions
DRUGDLBS1033
Sponsors
Dexa Medica Group
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serial Plasmin-antiplasmin complex (PAP complex) | 3 days | 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 |
Countries
Indonesia
Outcome results
None listed