Clinical trial NCT02196805: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chinese Healthy Volunteers
Keywords: bioequivalence
imported PROBUCOL table
Lorelco
marketed PROBUCOL tablet
Chang Tai
Lead sponsor: Otsuka Beijing Research Institute
Sponsor class: INDUSTRY
First posted: 2014-07-22
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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

Primary outcomes:
measure: BE parameters: AUC0-t
timeFrame: 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.
measure: BE parameters: Cmax
timeFrame: 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 outcomes:
measure: Pharmacokinetic Parameters: Cmax
timeFrame: 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.
measure: Pharmacokinetic Parameters: Tmax
timeFrame: 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
measure: Pharmacokinetic Parameters: AUC0-t
timeFrame: 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
measure: Pharmacokinetic Parameters: AUC0-∞
timeFrame: 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
measure: Pharmacokinetic Parameters: t1/2
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Clinical Pharmacology Research Center Peking Union Medical College Hospital
Study officials:
affiliation: Clinical Pharmacology Research Center Peking Union Medical College Hospital
name: Pei Hu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: