drugset / Trial / NCT01905878

Biological Half Life of DLBS1033 in Healthy Volunteers

NCT01905878

Phase 1/2 Completed 14 enrolled Indonesia University Dexa Medica Group · collab
RandomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2013-06
Primary completion
2013-09
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject DLBS1033 Protein / enzyme biologic 490 mg Oral
Subject DLBS1033 Protein / enzyme biologic 1470 mg Oral

Indications

No indication recorded.