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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004094
Receipt No. R000004889
Scientific Title Exploratory trials evaluating the pharmacokinetics of Quinidine and Verapamil after oral administration in healthy male subjects
Date of disclosure of the study information 2010/09/01
Last modified on 2010/10/26

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Basic information
Public title Exploratory trials evaluating the pharmacokinetics of Quinidine and Verapamil after oral administration in healthy male subjects
Acronym Exploratory trials evaluating the pharmacokinetics of Quinidine and Verapamil after oral administration in healthy male subjects
Scientific Title Exploratory trials evaluating the pharmacokinetics of Quinidine and Verapamil after oral administration in healthy male subjects
Scientific Title:Acronym Exploratory trials evaluating the pharmacokinetics of Quinidine and Verapamil after oral administration in healthy male subjects
Region
Japan

Condition
Condition Healthy male subjects
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the role of MDR1 and CYP3A4 in intestinal absorption of Quinidine and Verapamil.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetics of Quinidine and Verapamil
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Quinidine,Verapamil,Fexofenadine,Midazolam,Celiprolol and Itraconazole
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
45 years-old >=
Gender Male
Key inclusion criteria Key criteria to be considered for this study:
(1)Healthy male subjects
(2)The subject is capable of giving written consent prior to screening.
(3)The subject aged between 20 and 45 years inclusive at screening.
(4)The subject has a body mass index in the range of 17.6 to 28.0 kg/m2.
(5)The subject is able to abstain from smoking during the hospitalization.
Key exclusion criteria The following subjects shall be excluded from this study:
(1)The subject has any medical history that is not considered as eligible for
inclusion in this study by the investigator.
(2)The subject has the disease which needs a treatment at present.
(3)The subject is currently participating in another clinical study and is exposed to an investigational drug.
(4) The subject has any medical history of known allergy or hypersensitivity to quinidine, verapamil, fexofenadine, midazolam, celiprorol and itraconazole.
(5) The subject has donated whole blood">400mL" within the previous 3 months or ">200mL" within the previous 1 month, and components of blood(apheresis) within the previous 2 weeks.
(6) The subject has hypersensitivity to any drugs and foods.
(7) The subject has a history or current conditions of drug abuse or alcoholism.
(8)The subject is positive for HBs antigen, syphilis, HCV antibody, HIV antigen/antibody.
(9)The subject has any clinically relevant abnormality on vital sign, clinical laboratory test, ECG and medical examination. (The subject who admitted participation in this study in the judgement of investigator excludes.)
(10)Any subjects considered to be unsuitable for the study by the reseacher.
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Komatsuzaki
Organization Tsukuba International Clinical Pharmacology Clinic
Division name medical office
Zip code
Address 1-21-16 Kannondai Tsukuba city,Ibaraki,JAPAN
TEL 029-839-1150
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaaki Mochii
Organization Tsukuba International Clinical Pharmacology Clinic
Division name Clinical Trial Project Office
Zip code
Address 1-21-16 Kannondai Tsukuba city,Ibaraki,JAPAN
TEL 029-839-1150
Homepage URL
Email m-mochii@tsukuba-icp.jp

Sponsor
Institute APDD
Institute
Department

Funding Source
Organization APDD
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 07 Month 29 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2010 Year 11 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 24 Day
Last modified on
2010 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004889

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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