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CompletedNCT01590901Updated Jun 5, 2013

Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects

A Phase 1 interventional study of Probucol in Healthy, sponsored by Otsuka Beijing Research Institute. Completed at 1 site in China. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-05.

Sponsored by Otsuka Beijing Research Institute · Phase 1, Interventional, and Supportive care

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
20 Years to 40 Years
Sex
Male
01

Study summary

The Objectives of this study is to evaluate the pharmacokinetics and safety of multiple oral doses of probucol in healthy male subjects.

Read the detailed description

This is a single dose, single period, multiple administration, open-labeled trial in one investigation center.

The screening examination will be completed from Day -14 to Day -2 before investigational medicinal product (IMP) administration. The subjects will be hospitalized on Day -1. From Day 1 (the next day), the subjects will receive probucol twice daily (BID). for 14 consecutive days. On Day 18, the subjects can be discharged after the safety evaluation. The follow-up visit will occur on Day 6, 9, 12, 15, 19, 27 (totally 41 days) after the final dosing day.

02

Conditions studied

  • Healthy

Keywords

  • Pharmacokinetics
  • Probucol
  • healthy male subjects
03

In context

Lead sponsor

Otsuka Beijing Research Institute is the lead sponsor of 36 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Chinese.
  2. Gender: Male.
  3. Age 20 to 40 years, (at time of informed consent).
  4. Body mass index [BMI, body weight (kg) / height (m)2] between 19 and 26 kg/m2, inclusive.
  5. Nonsmokers (or former smokers): Urinary cotinine level satisfying the criteria for a nonsmoker established by the trial site (at time of screening examination).
  6. 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.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with hypersensitivity or a history of hypersensitivity to any drug (any prescription or over-the-counter [OTC] drug)
  2. 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.
  3. 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)
  4. Subjects with alcohol or drug dependence or a history of drug abuse
  5. Subjects who have a positive result in an infectious disease test or urine drug test (at time of screening examination)
  6. 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)
  7. Use of any other investigational drug within 16 weeks prior to scheduled IMP administration in the present trial
  8. 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
  9. Subjects whose body weight is less than 50 kg (at time of screening examination)
  10. Subjects who are scheduled for examination or treatment at any other hospital or clinic during the trial period
  11. Subjects otherwise judged by the investigator or sub investigator to be inappropriate for inclusion in the trial
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Other
    probucol in healthy male subjects

    multiple oral doses of probucol in single group of healthy male subjects

    Drug: Probucol

Interventions

  • DrugProbucol

    250mg (1 tablet) bid. p.o for 14 consecutive days

    Also known as: Lorelco

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic parameters

    Pharmacokinetic parameters: Day 1 (Plasma PK parameters over the 24h dosing period): Cmax, Cmax1, Cmax2, tmax1, tmax2, AUC (0-10)h, AUC (10-24)h, AUC24h, C24h; Day3,5,7,9,11,12,13:C24h; Day 14: Cmax, Cmax1, Cmax2, tmax1, tmax2, AUC (0-10)h, AUC (10-24)h, AUC24h, C24h, Clast, tlast, t1/2,z,Lambdaz, DF, CL/F, Vz/F, AUC_%Extrap; Accumulation evaluation parameters: Rpred, R14,ac(AUC24h), R14,ac(Cmax), R14,ac(C24h), R14,ac\[AUC(0-10h)\], R14,ac\[AUC(10-24h)\], R14,ac(Cmax1), R14,ac(Cmax2).

    Time frame: Day 1, 3, 5, 7, 9, 11, 12, 13, 14

07

Study locations

1 site
  • Clinical Pharmacology Research Center, Peking Union Medical College Hospital
    Beijing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01590901
Lead sponsor
Otsuka Beijing Research Institute
Responsible party
Sponsor
First posted
May 3, 2012
Start date
Feb 2012
Primary completion
Apr 2012
Completion
Jan 2013
Last update
Jun 5, 2013

Study contacts

Pei Hu, PHD
principal investigator · Clinical Pharmacology Research Center of Peking Union Medical College Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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