Safety and Efficacy of DLBS1033 in Healthy Subjects

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: DLBS1033; Drug: Placebo

• Registration Number: NCT01378585
• Lead Sponsor: Dexa Medica Group

Brief 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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-06
• Study First Submitted QC: 2011-06-21
• Study First Posted: 2011-06-22
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-21
• Last Update Posted: 2012-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment 1	DLBS1033	Test drug treatment: 3 x 490 mg DLBS1033 daily
Treatment 2	Placebo	Placebo treatment: 3 x 1 tablet daily

Primary Outcome Measures

Name	Time	Method
Safety	14 days	routine hematology (Hb, Ht, RBC, WBC, Platelet), erythrocyte sedimentation rate (ESR), liver function (ALT, AST, Gamma-GT, alkaline phosphatase), renal function (ureum, creatinine), lipid profile (total cholesterol, triglyceride, LDL-C, HDL-C), fasting blood glucose, routine urine parameters (glucose, bilirubin, ketones, specific gravity, blood, urinary pH, proteins, urobilinogen, nitrites, leucocyte esterase, and urine sediment), stool occult blood, ECG examination, clinical / physical examination

Secondary Outcome Measures

Name	Time	Method
Fibrinogen level	Day 1, 2, 7, and 14 of treatment
Thrombin time (TT)	Day 1, 2, 7, and 14 of treatment
prothrombin time (PT)	Day 1, 2, 7, and 14 of treatment
activated-partial thromboplastin time (aPTT)	Day 1, 2, 7, and 14 of treatment
Number of subjects with adverse events	Day 1 and 7 of treatment

Trial Locations

Locations (1)

PT Equilab International; 🇮🇩 Jakarta, Indonesia