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Safety and Efficacy of DLBS1033 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01378585
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : August 23, 2012
Sponsor:
Information provided by:
Dexa Medica Group

Study Description
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Brief Summary:

The objective of this study are:

  1. To evaluate the safety of DLBS1033 in comparison with placebo in healthy adult subject
  2. To evaluate the efficacy of DLBS1033 in comparison with placebo in healthy adult subject

Condition or disease Intervention/treatment Phase
Healthy Drug: DLBS1033 Drug: Placebo Not Applicable

Detailed Description:
This study is a 2-arm, randomized, double-blind, placebo controlled, cross-over study with a fixed dose regimen. The study will involve twenty (20) healthy subjects. The study will be a comparative study of safety and efficacy of DLBS1033 with placebo. Each study period will consist of 14 days treatment with a 2-week wash-out period in between. The evaluation of safety parameters will be performed at Day 1 (baseline), 7, and 14; while the efficacy parameters will be performed at Day 1, 2, 7, and 14.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Cross-over, and Fixed Dose Study to Evaluate the Safety and Efficacy of DLBS1033 in Healthy Subjects
Study Start Date : May 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment 1
Test drug treatment: 3 x 490 mg DLBS1033 daily
 Drug: DLBS1033
3 x 490 mg DLBS1033 daily
Placebo Comparator: Treatment 2
Placebo treatment: 3 x 1 tablet daily
 Drug: Placebo
3 x 1 tablet daily


Outcome Measures
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Primary Outcome Measures :
  1. Safety [ Time Frame: 14 days ]
    routine hematology (Hb, Ht, RBC, WBC, Platelet), erythrocyte sedimentation rate (ESR), liver function (ALT, AST, Gamma-GT, alkaline phosphatase), renal function (ureum, creatinine), lipid profile (total cholesterol, triglyceride, LDL-C, HDL-C), fasting blood glucose, routine urine parameters (glucose, bilirubin, ketones, specific gravity, blood, urinary pH, proteins, urobilinogen, nitrites, leucocyte esterase, and urine sediment), stool occult blood, ECG examination, clinical / physical examination


Secondary Outcome Measures :
  1. Fibrinogen level [ Time Frame: Day 1, 2, 7, and 14 of treatment ]
  2. Thrombin time (TT) [ Time Frame: Day 1, 2, 7, and 14 of treatment ]
  3. prothrombin time (PT) [ Time Frame: Day 1, 2, 7, and 14 of treatment ]
  4. activated-partial thromboplastin time (aPTT) [ Time Frame: Day 1, 2, 7, and 14 of treatment ]
  5. Number of subjects with adverse events [ Time Frame: Day 1 and 7 of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female 18 - 50 year-old at screening
  • Having good and stable health judged on the basis of medical history, physical examination, and routine laboratory
  • Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study

Exclusion Criteria:

  • Participating in other clinical trial within 4 weeks prior to screening
  • Had a major surgical procedure or dental procedure within 4 weeks prior to screening
  • History of any of the following medical conditions: haemophilia, past medical history of haemorrhagic stroke, acid peptic disease, easy bruising and frequent external bleeding
  • Any other known current medical condition, which is judged by the investigator could jeopardize subject's health or interfere with the study evaluation
  • Being on regular medication(s), including traditional medicine(s)
  • Pregnant or lactating women (urinary pregnancy test will be applied to women subjects during screening and just before treatment in each periods)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378585


Locations
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Indonesia
PT Equilab International
Jakarta, Indonesia, 12430
Sponsors and Collaborators
Dexa Medica Group
Investigators
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Principal Investigator: Danang A Yunaidi, Dr PT. Equilab International
More Information
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ClinicalTrials.gov Identifier: NCT01378585    
Other Study ID Numbers: DLBS1033
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012
Keywords provided by Dexa Medica Group:
DLBS1033
safety
fibrinolytic
fibrinogenolytic
antiplatelet