Biological Half Life of DLBS1033 in Healthy Volunteers

Healthy Condition Clinical Trial

Official title:

Biological Half Life of DLBS1033 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905878
• Other study ID #: halflifeDLBS1033
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 11, 2013
• Last updated: May 11, 2017
• Start date: June 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Condition

Intervention

Drug:
• DLBS1033

Locations

Country	Name	City	State
Indonesia	University of Indonesia	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Dexa Medica Group

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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