Safety and Efficacy of DLBS1033 in Healthy Subjects

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Dexa Medica

Status

Completed

Conditions

Healthy

Treatments

Drug: DLBS1033
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01378585
DLBS1033

Details and patient eligibility

About

The objective of this study are: To evaluate the safety of DLBS1033 in comparison with placebo in healthy adult subject To evaluate the efficacy of DLBS1033 in comparison with placebo in healthy adult subject

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

20 participants in 2 patient groups, including a placebo group

Treatment 1
Experimental group
Description:
Test drug treatment: 3 x 490 mg DLBS1033 daily
Treatment:
Drug: DLBS1033
Treatment 2
Placebo Comparator group
Description:
Placebo treatment: 3 x 1 tablet daily
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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