Safety and Pharmacokinetics of Probucol and Cilostazol
Information source: Korea Otsuka Pharmaceutical Co.,Ltd.
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Cilostazol (Drug); Probucol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Korea Otsuka Pharmaceutical Co.,Ltd. Official(s) and/or principal investigator(s):
In-Jin Jang, PhD, Principal Investigator, Affiliation: Seoul National University Hospital
Overall contact:
Yonghui Jeong, Phone: 82-2-3465-3956, Email: jeongyh@otsuka.co.kr
Summary
to investigate the safety and pharmacokinetics, in healthy adult male subjects
Clinical Details
Official title: Phase IV, Safety and Pharmacokinetics of Probucol and Cilostazol When Coadministered in Healthy Subjects
Study design: Treatment, Open Label, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetic parameters,
Number of adverse events
Secondary outcome: Physical exam, ECG, Vital signs and Laboratory tests, Drug interaction parameters
Detailed description:
Safety and Pharmacokinetics of Probucol and Cilostazol when co-administered in Health
Subjects
Eligibility
Minimum age: 20 Years.
Maximum age: 40 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Yonghui Jeong, Phone: 82-2-3465-3956, Email: jeongyh@otsuka.co.kr
Clinical Trial Center, Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting
In-Jin Jang, Principal Investigator
Additional Information
Starting date: October 2007
Ending date: December 2007
Last updated: November 13, 2007
|
