Safety and Efficacy of DLBS1033 in Healthy Subjects

NCT01378585 | Completed

• 1 other identifier: DLBS1033
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study are:

1. 1.To evaluate the safety of DLBS1033 in comparison with placebo in healthy adult subject
2. 2.To evaluate the efficacy of DLBS1033 in comparison with placebo in healthy adult subject

Conditions

Healthy

Keywords

DLBS1033; safety; fibrinolytic; fibrinogenolytic; antiplatelet

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (2)

Treatment 1

EXPERIMENTAL

Test drug treatment: 3 x 490 mg DLBS1033 daily

Drug: DLBS1033

Treatment 2

PLACEBO COMPARATOR

Placebo treatment: 3 x 1 tablet daily

Drug: Placebo

Interventions

DLBS1033 DRUG

3 x 490 mg DLBS1033 daily

Treatment 1

Placebo DRUG

3 x 1 tablet daily

Treatment 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (1)

PT Equilab International

Jakarta, Jakarta Special Capital Region, 12430, Indonesia

Location

MeSH Terms

Interventions

DLBS 1033

Study Officials

• Danang A Yunaidi, Dr

  PT Equilab International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 22, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 23, 2012

Record last verified: 2012-08

Locations

ID (1)