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Safety and Efficacy of DLBS1033 in Healthy Subjects

NCT ID: NCT01378585

Last Updated: 2012-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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DLBS1033 safety fibrinolytic fibrinogenolytic antiplatelet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment 1

Test drug treatment: 3 x 490 mg DLBS1033 daily

Group Type EXPERIMENTAL

DLBS1033

Intervention Type DRUG

3 x 490 mg DLBS1033 daily

Treatment 2

Placebo treatment: 3 x 1 tablet daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

3 x 1 tablet daily

Interventions

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DLBS1033

3 x 490 mg DLBS1033 daily

Intervention Type DRUG

Placebo

3 x 1 tablet daily

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dexa Medica Group

INDUSTRY

Sponsor Role lead

Principal Investigators

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Danang A Yunaidi, Dr

Role: PRINCIPAL_INVESTIGATOR

PT Equilab International

Locations

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PT Equilab International

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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DLBS1033

Identifier Type: -

Identifier Source: org_study_id