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Safety and Pharmacokinetics of Probucol and Cilostazol

Information source: Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Cilostazol (Drug); Probucol (Drug)

Phase: Phase 4

Status: Completed

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

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: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Clinical Trial Center, Seoul National University Hospital, Seoul 110-744, Korea, Republic of
Additional Information

Starting date: October 2007
Last updated: July 21, 2010

Page last updated: August 23, 2015

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