HealthyNCT01378585
Safety and Efficacy of DLBS1033 in Healthy Subjects
A study testing DLBS1033 in people with Healthy, run by Dexa Medica Group at 1 site in Indonesia.
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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DLBS1033
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- May 2011to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
PT Equilab International
Jakarta, Jakarta Special Capital Region, 12430
About this study
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
The objective of this study are:
- To evaluate the safety of DLBS1033 in comparison with placebo in healthy adult subject
- To evaluate the efficacy of DLBS1033 in comparison with placebo in healthy adult subject
Read the 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.
- Conditions
- Healthy
- Being tested
- DLBS1033, Placebo
- Keywords
- DLBS1033, safety, fibrinolytic, fibrinogenolytic, antiplatelet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLBS1033Drug
3 x 490 mg DLBS1033 daily
PlaceboDrug
3 x 1 tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Test drug treatment: 3 x 490 mg DLBS1033 daily Receives: Drug: DLBS1033 |
| Treatment 2 | Placebo comparator | Placebo treatment: 3 x 1 tablet daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (5)
Fibrinogen level
Measured: Day 1, 2, 7, and 14 of treatment
Thrombin time (TT)
Measured: Day 1, 2, 7, and 14 of treatment
prothrombin time (PT)
Measured: Day 1, 2, 7, and 14 of treatment
activated-partial thromboplastin time (aPTT)
Measured: Day 1, 2, 7, and 14 of treatment
Number of subjects with adverse events
Measured: Day 1 and 7 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Danang A Yunaidi, Dr, Principal investigator, PT Equilab International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378585
- Sponsor's protocol ID
- DLBS1033
- Status last verified
- Aug 2012
- First submitted
- 6 Jun 2011
- Last updated
- 23 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01378585
- Acronym / sponsor ID
- DLBS1033
- Conditions
- Healthy
- Keywords
- DLBS1033, safety, fibrinolytic, fibrinogenolytic, antiplatelet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study are:
- To evaluate the safety of DLBS1033 in comparison with placebo in healthy adult subject
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: DLBS1033Test drug treatment: 3 x 490 mg DLBS1033 daily |
| Treatment 2 | Placebo comparator | Drug: PlaceboPlacebo treatment: 3 x 1 tablet daily |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DLBS10333 x 490 mg DLBS1033 daily | Drug | Treatment 1 |
| Placebo3 x 1 tablet daily | Drug | Treatment 2 |
Primary outcome
Safety
Time frame: 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
5 secondary outcomes
Fibrinogen level
Time frame: Day 1, 2, 7, and 14 of treatment
Thrombin time (TT)
Time frame: Day 1, 2, 7, and 14 of treatment
prothrombin time (PT)
Time frame: Day 1, 2, 7, and 14 of treatment
activated-partial thromboplastin time (aPTT)
Time frame: Day 1, 2, 7, and 14 of treatment
Number of subjects with adverse events
Time frame: Day 1 and 7 of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danang A Yunaidi, Dr principal investigator
PT Equilab International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DLBS1033 in people with Healthy, run by Dexa Medica Group at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2012.