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A Bioequivalence Study Comparing a Single Oral Intake of an Imported PROBUCOL Tablet(Lorelco) With a Marketed PROBUCOL Tablet(Chang Tai) in Chinese Healthy Volunteers

NCT02196805 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-07-22

No results posted yet for this study

Summary

This study compares the pharmacokinetics characteristics of a single oral intake of an imported PROBUCOL tablet(Lorelco)(1\*250mg/tablet) with a marketed PROBUCOL tablet (Chang Tai)(1\*250mg/tablet) in healthy male volunteers to demonstrate they are bioequivalent.

Conditions

  • Chinese Healthy Volunteers

Interventions

DRUG

Group A: imported Probucol ( Lorelco)

Group A: take imported Probucol( Lorelco) (250mg/tablet), Qd, P.O.

DRUG

Group B: Marketed Probucol ( Chang Tai)

Group B: take Marketed Probucol(Chang Tai)(250mg/tablet), Qd, P.O.

Sponsors & Collaborators

  • Otsuka Beijing Research Institute

    lead INDUSTRY

Principal Investigators

  • Pei Hu, Dr. · Clinical Pharmacology Research Center Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-09-30
Completion
2009-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02196805 on ClinicalTrials.gov