The Objectives of this study is to evaluate the pharmacokinetics and safety of multiple oral
doses of probucol in healthy male subjects.
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01590901
Ages eligible for Study
20 Years to 40 Years
Genders eligible for Study
Accepts Healthy Volunteers
Age 20 to 40 years, (at time of informed consent).
Body mass index [BMI, body weight (kg) / height (m)2] between 19 and 26 kg/m2, inclusive.
Nonsmokers (or former smokers): Urinary cotinine level satisfying the criteria for a nonsmoker established by the trial site (at time of screening examination).
Subjects judged by the investigator to be healthy based on the medical history, physical examination, vital signs, 12 lead ECG, the results of serological test
(HIV/HCV Ab, HBsAg and Syphilis Ab) and clinical laboratory tests, etc.
Subjects with hypersensitivity or a history of hypersensitivity to any drug (any prescription or over-the-counter [OTC] drug)
Subjects who meet any of the following lipid criteria in the fasting state (at time of screening examination)
LDL-C: ≥ 140 mg/dL
TC: ≥ 220 mg/dL
HDL-C: < 40 mg/dL
TG: ≥ 150 mg/dL
LDL-C value will be directly measured or calculated by the Friedewald formula. Friedewald Formula: LDL-C = TC - HDL-C - TG/5 (When TG value is less than 400 mg/dL) LDL-C value will be directly measured when TG value is 400 mg/dL or greater.
Subjects with electrocardiogram (ECG) results showing AV block or with both QTc and QRS width outside the standard values of the ECG laboratory (at time of screening examination)
Subjects with alcohol or drug dependence or a history of drug abuse
Subjects who have a positive result in an infectious disease test or urine drug test
(at time of screening examination)
Use of any of the following within the specified period prior to scheduled investigational medicinal product (IMP) administration
All other prescription and OTC drugs (within 2 weeks prior to scheduled IMP administration)
Alcohol and caffeine-containing products (within 1 week prior to scheduled IMP administration)
Use of any other investigational drug within 16 weeks prior to scheduled IMP administration in the present trial
Plasmapheresis or plateletpheresis within 2 weeks or whole blood collection (blood donation, etc) cumulatively exceeding 200 mL within 4 weeks, 400 mL within 12 weeks, or 1200 mL within 1 year prior to scheduled IMP administration
Subjects whose body weight is less than 50 kg (at time of screening examination)
Subjects who are scheduled for examination or treatment at any other hospital or clinic during the trial period
Subjects otherwise judged by the investigator or sub investigator to be inappropriate for inclusion in the trial
All locations for NCT01590901
Clinical Pharmacology Research Center, Peking Union Medical College Hospital
View full eligibility
Tris trial is registered with FDA with number: NCT01590901. The sponsor of the trial is Otsuka Beijing Research Institute and it is looking for 12 volunteers for the current phase.
Official trial title: The Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects
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