Clinical trial NCT01378585: Safety and Efficacy of DLBS1033 in Healthy Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: DLBS1033
safety
fibrinolytic
fibrinogenolytic
antiplatelet
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2011-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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 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)

Primary outcomes:
measure: Safety
timeFrame: 14 days
Secondary outcomes:
measure: Fibrinogen level
timeFrame: Day 1, 2, 7, and 14 of treatment
measure: Thrombin time (TT)
timeFrame: Day 1, 2, 7, and 14 of treatment
measure: prothrombin time (PT)
timeFrame: Day 1, 2, 7, and 14 of treatment
measure: activated-partial thromboplastin time (aPTT)
timeFrame: Day 1, 2, 7, and 14 of treatment
measure: Number of subjects with adverse events
timeFrame: Day 1 and 7 of treatment
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: PT Equilab International
Study officials:
affiliation: PT Equilab International
name: Danang A Yunaidi, Dr
role: PRINCIPAL_INVESTIGATOR
References: