UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004173 |
|---|---|
| Receipt number | R000004998 |
| 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 Meloxicam in Healthy Adult Male Subjects |
| Date of disclosure of the study information | 2010/10/14 |
| Last modified on | 2012/09/15 13:44:29 |
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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 Meloxicam in Healthy Adult Male Subjects
Acronym
Comparative Pharmacokinetic Study of
Meloxicam 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 Meloxicam in Healthy Adult Male Subjects
Scientific Title:Acronym
Comparative Pharmacokinetic Study of
Meloxicam 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 meloxicam 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 meloxicam
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 7.5 mg tablet of
meloxicam
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)Persons with diseases of heart, lung, kidney, blood, central nervous system and metabolic system, peptic ulcer, inflammatory enteropathy, hypertension, asthma and diseases of skeletal muscles, etc. and those with a history of any of the above diseases.
3)Persons with hypersensitivity or allergy to drugs, foods, etc.
5)Persons who are smoking or those have stopped smoking in 6 months. (the cotinine test is conducted if necessary.)
6)Persons who are drug-dependent or those suspected to be drug-dependent. (drug screening is conducted if necessary.)
7)Habitual alcohol drinkers (persons with 50 g or more of alcohol intake per day).
8)Total bilirubin or direct bilirubin, AST, ALT and ALP is 1.5 times higher, or other liver and renal function tests items are 1.25 times higher than the upper limits of normal at the sites.
9)Persons who underwent 200 mL or more of blood collection within one month, blood component donation (plasma or platelet) within two weeks or those who underwent more than 400 mL blood collection within 3 months before administration of the study drug.
10)Persons who participated in a phase I study on drugs containing new active ingredient within 4 months, or those who participated in other studies and received administration within 3 months, before administration of the study drug (For patch test, those who received within one month before administration of the study drug). And persons who participated in any of the above studies and received administration outside the defined period shall also be excluded, if determined to be inappropriate for participation in the study, considering the characteristics of the previous investigational product.
11)Other persons determined by the principal investigator to be inappropriate for the study.
Target sample size
120
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 | 10 | Month | 14 | 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 | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 08 | 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=R000004998
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