Safety and Efficacy of DLBS1033 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Dexa Medica Group
ClinicalTrials.gov Identifier:
NCT01378585
First received: June 6, 2011
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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 Intervention
Healthy
Drug: DLBS1033
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Dexa Medica Group:

Primary Outcome Measures:
  • Safety [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    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:
  • Fibrinogen level [ Time Frame: Day 1, 2, 7, and 14 of treatment ] [ Designated as safety issue: No ]
  • Thrombin time (TT) [ Time Frame: Day 1, 2, 7, and 14 of treatment ] [ Designated as safety issue: Yes ]
  • prothrombin time (PT) [ Time Frame: Day 1, 2, 7, and 14 of treatment ] [ Designated as safety issue: Yes ]
  • activated-partial thromboplastin time (aPTT) [ Time Frame: Day 1, 2, 7, and 14 of treatment ] [ Designated as safety issue: Yes ]
  • Number of subjects with adverse events [ Time Frame: Day 1 and 7 of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: May 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01378585

Locations
Indonesia
PT Equilab International
Jakarta, Indonesia, 12430
Sponsors and Collaborators
Dexa Medica Group
Investigators
Principal Investigator: Danang A Yunaidi, Dr PT Equilab International
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01378585     History of Changes
Other Study ID Numbers: DLBS1033
Study First Received: June 6, 2011
Last Updated: August 21, 2012
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Dexa Medica Group:
DLBS1033
safety
fibrinolytic
fibrinogenolytic
antiplatelet

ClinicalTrials.gov processed this record on October 02, 2014