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.

Study Overview

• Status: Completed
• Conditions: Healthy Condition
• Intervention / Treatment: Drug: DLBS1033

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 10430
    • University of Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single dose DLBS1033; 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
Experimental: steady state of DLBS1033; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Dexa Medica Group
• Investigators: Principal Investigator: Anggi Gayatri, MD, SpFK, Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 11, 2013
• First Submitted That Met QC Criteria: July 18, 2013
• First Posted (Estimate): July 23, 2013

Study Record Updates

• Last Update Posted (Actual): May 12, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: halflifeDLBS1033