HealthyPhase 1NCT00689858
Study to Assess the Effect of Pharmacokinetics/Pharmacodynamics (PK/PD) Interaction After co-Administration of Cilostazol With Ginkgo Biloba or Placebo
A Phase 1 study of Healthy, run by SK Chemicals Co., Ltd. at 3 sites in South Korea.
Trial summary
TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase I study in healthy Volunteers were designed Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesSouth Korea
- Study dates
- May 2007to Jul 2008
- Phase
- Phase 1
- 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 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male adult volunteer between 19 and 45 years of age and within 15% of ideal body weight by broca's formula.
- the subjects who doesn't have any congenital or chronic diseases and symptoms or signs of diseases after physical examinations.]
Who cannot join
- the subject who has abnornal lab. ( In particular, AST or ALT > 1.25 times of upper limit / Total bilirubin > 1.5 times of upper limit/170,000 < Platelet < 360,000 / PT or aPTT or BT> >upper limit
- the subject who receive any metabolic enzyme inducing or inhibiting drugs like barbiturates or drink excess alcohol within 1 month prior to the study.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
INJE University Pusan Paik Hospital
Pusan
SK chemicals
Seoul, 110-744
SKChemicals
Seoul
About this study
Official title: Clinical Trial to Assessment the PK/PD Characteristics and Safety After co-Administration of Cilostazol With Ginkgo Biloba or Placebo in Healthy Subject.
TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase I study in healthy Volunteers were designed
- Conditions
- Healthy
- Being tested
- Cilostazol, Ginkgo biloba and placebo
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol, Ginkgo biloba and placeboDrug
dosing time
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Period 1: Cilostazol, Ginkgo biloba Period 2:Cilostazol, placebo Receives: Drug: Cilostazol, Ginkgo biloba and placebo |
| 2 | Active comparator | Period 1: Cilostazol, placebo Period 2: Cilostazol, Ginkgo biloba Receives: Drug: Cilostazol, Ginkgo biloba and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concetration of Cilostazol at steady state
Measured: within 12hrs after cilostazol
Secondary outcomes (1)
PD parameter: change from baseline after administration (change value of aggregation %)
Measured: within 12hrs after cilostazol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startMay 2007
- Primary completionJul 2008
- Study completionJul 2008
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jae Gook Shin, MD,PhD, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689858
- Sponsor's protocol ID
- GETC_DDI_I_2008
- Status last verified
- Jun 2008
- First submitted
- 2 Jun 2008
- Last updated
- 13 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assessment the PK/PD Characteristics and Safety After co-Administration of Cilostazol With Ginkgo Biloba or Placebo in Healthy Subject.
- ClinicalTrials.gov ID
- NCT00689858
- Acronym / sponsor ID
- GETC_DDI_I_2008
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 4 Jun 2008 (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.
TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase I study in healthy Volunteers were designed
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 |
|---|---|---|
| 1 | Experimental | Drug: Cilostazol, Ginkgo biloba and placeboPeriod 1: Cilostazol, Ginkgo biloba Period 2:Cilostazol, placebo |
| 2 | Active comparator | Drug: Cilostazol, Ginkgo biloba and placeboPeriod 1: Cilostazol, placebo Period 2: Cilostazol, Ginkgo biloba |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy male adult volunteer between 19 and 45 years of age and within 15% of ideal body weight by broca's formula.
- the subjects who doesn't have any congenital or chronic diseases and symptoms or signs of diseases after physical examinations.]
Key exclusion criteria (2 listed)
- the subject who has abnornal lab. ( In particular, AST or ALT > 1.25 times of upper limit / Total bilirubin > 1.5 times of upper limit/170,000 < Platelet < 360,000 / PT or aPTT or BT> >upper limit
- the subject who receive any metabolic enzyme inducing or inhibiting drugs like barbiturates or drink excess alcohol within 1 month prior to the study.
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 |
|---|---|---|
| Cilostazol, Ginkgo biloba and placebodosing time | Drug | 1, 2 |
Primary outcome
Maximum plasma concetration of Cilostazol at steady state
Time frame: within 12hrs after cilostazol
1 secondary outcome
PD parameter: change from baseline after administration (change value of aggregation %)
Time frame: within 12hrs after cilostazol
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 13 Jan 2009.
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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.
Jae Gook Shin, MD,PhD principal investigator
Inje University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Healthy, run by SK Chemicals Co., Ltd. at 3 sites in South Korea.
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 2 inclusion and 2 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 13 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Maximum plasma concetration of Cilostazol at steady state (time frame: within 12hrs after cilostazol). 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 13 Jan 2009.