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Completed

NCT Number: 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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Pharmacology Research Center Peking Union Medical College Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group A: imported Probucol ( Lorelco)

Drug

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

Group B: Marketed Probucol ( Chang Tai)

Drug

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

Primary outcomes

  1. BE parameters: AUC0-t

    Time frame: 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.

  2. BE parameters: Cmax

    Time frame: 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

  1. Pharmacokinetic Parameters: Cmax

    Time frame: 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.

  2. Pharmacokinetic Parameters: Tmax

    Time frame: 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

  3. Pharmacokinetic Parameters: AUC0-t

    Time frame: 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

  4. Pharmacokinetic Parameters: AUC0-∞

    Time frame: 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

  5. Pharmacokinetic Parameters: t1/2

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Otsuka Beijing Research Institute

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 22, 2014
Registry last updated
Jul 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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