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

Not Applicable

Completed

• Conditions: Chinese Healthy Volunteers

• Registration Number: NCT02196805
• Lead Sponsor: Otsuka Beijing Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-08-25
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-20
• Last Update Submitted: 2014-07-20
• Study First Posted: 2014-07-22
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Clinical Pharmacology Research Center Peking Union Medical College Hospital; 🇨🇳 Beijing, China