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

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.

Study Overview

• Status: Completed
• Conditions: Chinese Healthy Volunteers
• Intervention / Treatment: Drug: Group A: imported Probucol ( Lorelco); Drug: Group B: Marketed Probucol ( Chang Tai)

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Group A: imported Probucol ( Lorelco); Group A: take imported Probucol( Lorelco) (250mg/tablet), Qd, P.O.
Experimental: 2	Drug: Group B: Marketed Probucol ( Chang Tai); Group B: take Marketed Probucol(Chang Tai)(250mg/tablet), Qd, P.O.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
BE parameters: AUC0-t	blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
BE parameters: Cmax	blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic Parameters: Cmax	blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
Pharmacokinetic Parameters: Tmax	blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
Pharmacokinetic Parameters: AUC0-t	blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
Pharmacokinetic Parameters: AUC0-∞	blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
Pharmacokinetic Parameters: t1/2	blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration

Collaborators and Investigators

• Sponsor: Otsuka Beijing Research Institute
• Investigators: Principal Investigator: Pei Hu, Dr., Clinical Pharmacology Research Center Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: August 25, 2009
• First Submitted That Met QC Criteria: July 20, 2014
• First Posted (Estimate): July 22, 2014

Study Record Updates

• Last Update Posted (Estimate): July 22, 2014
• Last Update Submitted That Met QC Criteria: July 20, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: bioequivalence; imported PROBUCOL table; Lorelco; marketed PROBUCOL tablet; Chang Tai
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Protective Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Antioxidants; Probucol
• Other Study ID Numbers: 009-09-801-01