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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004173
Receipt No. 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

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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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004998

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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