Safety and Efficacy of DLBS1033 in Healthy Subjects

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.

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)