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 Details — Status: Completed

Administrative data

• NCT number: NCT01378585
• Other study ID #: DLBS1033
• Status: Completed
• Phase: N/A
• First received: June 6, 2011
• Last updated: August 21, 2012
• Start date: May 2011
• Est. completion date: July 2011

Study information

• Verified date: August 2012
• Source: Dexa Medica Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

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

• Healthy

Intervention

Drug:
• DLBS1033
3 x 490 mg DLBS1033 daily
• Placebo
3 x 1 tablet daily

Locations

Country	Name	City	State
Indonesia	PT Equilab International	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dexa Medica Group

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	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	14 days	Yes
Secondary	Fibrinogen level		Day 1, 2, 7, and 14 of treatment	No
Secondary	Thrombin time (TT)		Day 1, 2, 7, and 14 of treatment	Yes
Secondary	prothrombin time (PT)		Day 1, 2, 7, and 14 of treatment	Yes
Secondary	activated-partial thromboplastin time (aPTT)		Day 1, 2, 7, and 14 of treatment	Yes
Secondary	Number of subjects with adverse events		Day 1 and 7 of treatment	Yes