Biological Half Life of DLBS1033 in Healthy Volunteers

Biological Half Life of DLBS1033 in Healthy Volunteers

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.

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)