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
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 |
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
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | PT Equilab International | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Dexa Medica Group |
Indonesia,
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 |
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