Safety and Efficacy of DLBS1033 in Healthy Subjects

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:

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

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