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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003644
Receipt No. R000004411
Scientific Title Global Clinical Study on Ethnic Differences in Drug Metabolism Based on the Joint Statement by the Japanese, Chinese and Korean Ministers of Health: Clinical Pharmacokinetic Study of Simvastatin in Healthy Adult Male Subjects.
Date of disclosure of the study information 2010/06/01
Last modified on 2012/09/15

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Basic information
Public title Global Clinical Study on Ethnic Differences in Drug Metabolism Based on the Joint Statement by the Japanese, Chinese and Korean Ministers of Health: Clinical Pharmacokinetic Study of Simvastatin in Healthy Adult Male Subjects.
Acronym Comparative Pharmacokinetic Study of
Simvastatin among Japan, Korea, China, and USA.
Scientific Title Global Clinical Study on Ethnic Differences in Drug Metabolism Based on the Joint Statement by the Japanese, Chinese and Korean Ministers of Health: Clinical Pharmacokinetic Study of Simvastatin in Healthy Adult Male Subjects.
Scientific Title:Acronym Comparative Pharmacokinetic Study of
Simvastatin among Japan, Korea, China, and USA.
Region
Japan Asia(except Japan) North America

Condition
Condition Healthy adult male subjects
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate whether or not there are
ethnic differences in the pharmacokinetics of the marketed simvastatin in healthy adult Japanese, Chinese and Korean male subjects based on the same protocol among the three countries. For comparison, a US clinical study in European Caucasians is conducted on the same protocol.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Pharmacokinetic parameters of simvastatin
Key secondary outcomes Safety

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 Educational,Counseling,Training
Type of intervention
Medicine
Interventions/Control_1 Single administration of 20 mg tablet of simvastatin
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
35 years-old >=
Gender Male
Key inclusion criteria 1) Those who are capable of providing written informed consent.
2) Men aged 20 to 35 years at the time of
signing informed consent.
3) BMI of 18.5 to <30.0 and body weight of 50.0 to 100.0 kg at screening.
4) Those who are determined by the
investigator to be healthy in the screening test and eligible for the study.
Key exclusion criteria 1)Organopathy involving the heart, lung, liver and/or kidney, etc.
2)A history of diseases involving the heart, lung, kidney, blood (such as coagulation system disorder), central nervous system and metabolic system that may interfere with the study.
3)Hypothyroidism, genetic myopathy or family history of it, history of drug-induced myopathy
4)Hypersensitivity or allergies to drugs, food, etc. (Particularly, a history of allergy to or adverse reactions associated with statin-type antihyperlipidemia drugs)
5)Oral administration of drugs such as over-the-counter drugs, health foods (supplements) that may affect metabolism of the test drug, grapefruit and drink/food including grapefruit within 1 week prior to the study drug administration, or taking drink including caffeine or green tea within 3 days prior to the study drug administration, or the necessity for using other medications before study completion.
6)Smokers or a smoking history within the last 6 months. (The cotinine test is performed, if necessary)
7)Drug abuse or suspicion of drug abuse. (The drug screening test is performed, if necessary)
8)Alcohol drinkers (daily alcohol intake of 50 g or more).
9)Total bilirubin or direct bilirubin is 1.5 times higher, AST, ALT and ALP is 2.5 times higher, or other liver and renal function tests items are 1.25 times higher than the upper limits of normal at the sites. The creatinine clearance (calculated by Cockcroft-Gault formula) is lower than the normal range at the sites.
10)Transfusion of 200 mL or more within 1 month prior to study drug administration, blood component donation (plasma or platelet) within 2 weeks, or blood collection of 400 mL or more within 3 months.
11)Those who are determined by the investigator to be not suitable as subjects of the study.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Kawai
Organization Toho University School of Medicine
Division name Division of Rheumatology, Department of Internal Medicine
Zip code
Address 6-11-1 Omori-nishi, Ota-ku, Tokyo, Japan
TEL 03-3762-4151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Kawai
Organization Toho University School of Medicine
Division name Division of Rheumatology, Department of Internal Medicine
Zip code
Address 6-11-1 Omori-nishi, Ota-ku, Tokyo, Japan
TEL 03-3762-4151
Homepage URL
Email skawai@med.toho-u.ac.jp

Sponsor
Institute Research Group of Global Clinical Study on Ethnic Differences in Drug Metabolism
Based on the Announcement by the Japanese, Chinese and Korean Ministers of Health, Labor and Welfare
Institute
Department

Funding Source
Organization Research Grant from Japanese Ministry of
Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 北里大学臨床薬理研究所(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 06 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 05 Month 20 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 05 Month 20 Day
Last modified on
2012 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004411

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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