UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003644 |
|---|---|
| Receipt number | 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 13:42:43 |
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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
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
skawai@med.toho-u.ac.jp
Sponsor or person
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
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004411
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| Registered date | File name |
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| Registered date | File name |
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