NCT01378585

Safety and Efficacy of DLBS1033 in Healthy Subjects

A Randomized, Double Blind, Placebo Controlled, Cross-over, and Fixed Dose Study to Evaluate the Safety and Efficacy of DLBS1033 in Healthy Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DLBS1033	3 x 490 mg DLBS1033 daily
DRUG	Placebo	3 x 1 tablet daily

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-06-22
• Last updated: 2012-08-23

Locations

1 site across 1 country: Indonesia