Status:
COMPLETED
Biological Half Life of DLBS1033 in Healthy Volunteers
Lead Sponsor:
Indonesia University
Collaborating Sponsors:
Dexa Medica Group
Conditions:
Healthy Condition
Eligibility:
MALE
18-55 years
Phase:
PHASE1
PHASE2
Brief 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 molecula...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01905878
Start Date
June 1 2013
End Date
December 1 2013
Last Update
May 12 2017
Active Locations (1)
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1
University of Indonesia
Jakarta, Indonesia, 10430