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

NCT ID: NCT02196805

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Group A: imported Probucol ( Lorelco)

Intervention Type: DRUG

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

2

Group Type: EXPERIMENTAL

Group B: Marketed Probucol ( Chang Tai)

Intervention Type: DRUG

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

Interventions

Group A: imported Probucol ( Lorelco)

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

Intervention Type: DRUG

Group B: Marketed Probucol ( Chang Tai)

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Chinese Male, aged between 18 and 40 years (at time of informed consent), extremes included
• Non-smokers
• Normal weight as defined by a Quetelet body mass index range of 18.0 - 26.0 kg/m2, extremes included
• Subjects judged by the investigator or sub investigator to be healthy based on the physical examination, medical history, vital signs, electrocardiogram (ECG), and the results of clinical laboratory tests
• Provided signed informed consent prior to beginning protocol-specific procedures, indicating that they understood the purpose of this study
• Willing to adhere to the study procedures described in this protocol

Exclusion Criteria

• History of respiratory system disease, cardiovascular disease, Renal and Urogenital Disease, Gastrointestinal disease, hematological disease, Neuropsychiatric disease, endocrine diseases, hepatic disease or any other disease or physical condition which could have interfered with the interpretation of the study results
• Known hypersensitivity history to any prescription drug or over-the-counter medication
• Use of the following medications or products during the periods specified below:

Any medication within 14 days prior to scheduled study drug administration; Alcohol and caffeine within 7 days prior to scheduled study drug administration; Grapefruit or grapefruit products within 14 days prior to scheduled study drug administration

• Participation in any other clinical trial within 12 weeks prior to scheduled study drug administration, or intention to participate any other clinical trial during the course of the study
• Significant loss or donation of blood or plasma (200 mL) within 30 days prior to the start of the study
• Body weight <50kg
• History of drug abuse within past 5 years or positive urine drug screen results
• Subjects who test positive in HIV,HCV antibody,HBS antigen
• Otherwise judged by the investigator to be inappropriate for inclusion in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Otsuka Beijing Research Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Otsuka Beijing Research Institute

Principal Investigators

Pei Hu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacology Research Center Peking Union Medical College Hospital

Locations

Clinical Pharmacology Research Center Peking Union Medical College Hospital

Beijing, , China

Countries

China

Other Identifiers

009-09-801-01

Identifier Type: -

Identifier Source: org_study_id