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Completed

NCT Number: NCT01905878

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.

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Key information

Conditions

Healthy Condition

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Indonesia

Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DLBS1033

Drug

Primary outcomes

  1. Serial Plasmin-antiplasmin complex (PAP complex)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Dexa Medica Group

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 23, 2013
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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