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Safety and Efficacy of DLBS1033 in Healthy Subjects

Healthy Clinical Trial

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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01378585
Study type Interventional
Source Dexa Medica Group
Contact
Status Completed
Phase N/A
Start date May 2011
Completion date July 2011
View Details
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