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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:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689858

Locations
Korea, Republic of
INJE University Pusan Paik Hospital
Pusan, Korea, Republic of
SK chemicals
Seoul, Korea, Republic of, 110-744
SKChemicals
Seoul, Korea, Republic of
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
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Respiratory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 24, 2014