Safety and Pharmacokinetics of Probucol and Cilostazol
Phase IV, Safety and Pharmacokinetics of Probucol and Cilostazol When Coadministered in Healthy Subjects
1 other identifier
interventional
32
1 country
1
Brief Summary
to investigate the safety and pharmacokinetics, in healthy adult male subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 healthy
Started Oct 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 25, 2007
CompletedFirst Posted
Study publicly available on registry
October 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedMarch 4, 2022
July 1, 2010
7 months
October 25, 2007
February 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic parameters, Number of adverse events
during study follow-up period
Secondary Outcomes (1)
Physical exam, ECG, Vital signs and Laboratory tests, Drug interaction parameters
During study follow-up period
Study Arms (2)
1
OTHERTwo compartments with cross-over and parallel
2
OTHERTwo compartments with cross-over and parallel
Interventions
Eligibility Criteria
You may qualify if:
- Korean
- Gender: Male
- Age: Over 20 and Under 40years, at time of informed consent
- body weight: BMI over 19.0 and Under 25.0
- Subjects who meet the following criteria at the time of the screening examination
- Subjects who have given their written informed consent prior to participation in the study
- Subjects who are reliable and willing to make themselves available for the duration of the study and follow the study protocol
You may not qualify if:
- History or clinical evidence of significant respiratory, cardiovascular, renal, gastrointestinal, hepatic, endocrine, hematologic, neurologic, psychiatric, or other chronic disease, alcoholism, or drug abuse
- Present or previous significant drug allergy to any prescription or over the counter medication
- Blood collection exceeding 200ml within 4 weeks, 400ml within 12 weeks, or 1200ml within one year prior to scheduled study drug administration
- Body weight: under 50Kg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Center, Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (1)
Kim KP, Kim BH, Lim KS, Kim TE, Shin SG, Jang IJ, Yu KS. Potential interactions between cilostazol and probucol: a two-part, single-dose, open-label study in healthy Korean male volunteers. Clin Ther. 2009 Oct;31(10):2098-106. doi: 10.1016/j.clinthera.2009.10.005.
PMID: 19922880DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
In-Jin Jang, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2007
First Posted
October 26, 2007
Study Start
October 1, 2007
Primary Completion
May 1, 2008
Study Completion
August 1, 2008
Last Updated
March 4, 2022
Record last verified: 2010-07