Safety and Efficacy of DLBS1033 in Healthy Subjects

A Randomized, Double Blind, Placebo Controlled, Cross-over, and Fixed Dose Study to Evaluate the Safety and Efficacy of DLBS1033 in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: DLBS1033; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 12430
    • PT Equilab International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	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	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Fibrinogen level	Day 1, 2, 7, and 14 of treatment
Thrombin time (TT)	Day 1, 2, 7, and 14 of treatment
prothrombin time (PT)	Day 1, 2, 7, and 14 of treatment
activated-partial thromboplastin time (aPTT)	Day 1, 2, 7, and 14 of treatment
Number of subjects with adverse events	Day 1 and 7 of treatment

Collaborators and Investigators

• Sponsor: Dexa Medica Group
• Investigators: Principal Investigator: Danang A Yunaidi, Dr, PT. Equilab International

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: June 6, 2011
• First Submitted That Met QC Criteria: June 21, 2011
• First Posted (Estimate): June 22, 2011

Study Record Updates

• Last Update Posted (Estimate): August 23, 2012
• Last Update Submitted That Met QC Criteria: August 21, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: safety; antiplatelet; fibrinolytic; DLBS1033; fibrinogenolytic
• Other Study ID Numbers: DLBS1033