NCT02196805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2009

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

August 25, 2009

Last Update Submit

July 20, 2014

Conditions

Chinese Healthy Volunteers

Keywords

bioequivalenceimported PROBUCOL tableLorelcomarketed PROBUCOL tabletChang Tai

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

1

EXPERIMENTAL
Drug: Group A: imported Probucol ( Lorelco)

2

EXPERIMENTAL
Drug: Group B: Marketed Probucol ( Chang Tai)

Interventions

Group A: imported Probucol ( Lorelco)DRUG

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

1
Group B: Marketed Probucol ( Chang Tai)DRUG

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

2

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacology Research Center Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Interventions

Probucol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Pei Hu, Dr.

    Clinical Pharmacology Research Center Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 25, 2009

First Posted

July 22, 2014

Study Start

March 1, 2009

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

July 22, 2014

Record last verified: 2014-07

Locations

CN(1)