Study to Assess the Effect of Pharmacokinetics/Pharmacodynamics (PK/PD) Interaction After co-Administration of Cilostazol With Ginkgo Biloba or Placebo
This study has been completed.
Sponsor:
SK Chemicals Co.,Ltd.
Information provided by:
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00689858
First received: June 2, 2008
Last updated: January 12, 2009
Last verified: June 2008
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Purpose
TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase I study in healthy Volunteers were designed
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Cilostazol, Ginkgo biloba and placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by SK Chemicals Co.,Ltd.:
Primary Outcome Measures:
- Maximum plasma concetration of Cilostazol at steady state [ Time Frame: within 12hrs after cilostazol ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- PD parameter: change from baseline after administration (change value of aggregation %) [ Time Frame: within 12hrs after cilostazol ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | May 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Period 1: Cilostazol, Ginkgo biloba Period 2:Cilostazol, placebo
|
Drug: Cilostazol, Ginkgo biloba and placebo
dosing time
|
|
Active Comparator: 2
Period 1: Cilostazol, placebo Period 2: Cilostazol, Ginkgo biloba
|
Drug: Cilostazol, Ginkgo biloba and placebo
dosing time
|
Eligibility| Ages Eligible for Study: | 19 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.]
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689858
Locations
| Korea, Republic of | |
| INJE University Pusan Paik Hospital | |
| Pusan, Korea, Republic of | |
| SKChemicals | |
| Seoul, Korea, Republic of | |
| SK chemicals | |
| Seoul, Korea, Republic of, 110-744 | |
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Investigators
| Principal Investigator: | Jae Gook Shin, MD,PhD | Inje University |
More Information
No publications provided
| Responsible Party: | Clinical Research Team Organization: SK Chemicals Co.,Ltd., SK Chemicals Co.,Ltd. |
| ClinicalTrials.gov Identifier: | NCT00689858 History of Changes |
| Other Study ID Numbers: | GETC_DDI_I_2008 |
| Study First Received: | June 2, 2008 |
| Last Updated: | January 12, 2009 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by SK Chemicals Co.,Ltd.:
|
Healthy volunteers |
Additional relevant MeSH terms:
|
Cilostazol Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors Vasodilator Agents Neuroprotective Agents |
Protective Agents Physiological Effects of Drugs Central Nervous System Agents Phosphodiesterase 3 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 19, 2013