Unique ID issued by UMIN | UMIN000002968 |
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Receipt number | R000003601 |
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 Moxifloxacin in Healthy Adult Male Subjects. |
Date of disclosure of the study information | 2010/02/01 |
Last modified on | 2012/09/15 13:40:55 |
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 Moxifloxacin in Healthy Adult Male Subjects.
Comparative Pharmacokinetic Study of Moxifloxacin among Japan, Korea, China, and USA.
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 Moxifloxacin in Healthy Adult Male Subjects.
Comparative Pharmacokinetic Study of Moxifloxacin among Japan, Korea, China, and USA.
Japan | Asia(except Japan) | North America |
Healthy adult male subjects
Not applicable |
Others
YES
To investigate whether or not there are ethnic differences in the pharmacokinetics of the marketed moxifloxacin 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.
Pharmacokinetics
Confirmatory
Explanatory
Not applicable
Pharmacokinetic parameters of moxifloxacin
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Educational,Counseling,Training
Medicine |
Single administration of 400 mg tablet of moxifloxacin
20 | years-old | <= |
35 | years-old | >= |
Male
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.
1) Organopathy involving the heart (QTc prolongation* etc.), lung, liver and/or kidney, etc., and hypokalemia.
2) A history of diseases involving the heart, lung, kidney, blood (such as coagulation system disorder), central nervous system, metabolic system and skeletal muscle system that may interfere with the study.
3) Hypersensitivity or allergies to drugs, food, etc. (Particularly, a history of allergy to or adverse reactions associated with quinolone antibacterials)
4) Oral administration of drugs such as over-the-counter drugs, supplements or health foods within 1 week prior to the study drug administration, or the necessity for using other medications before study completion.
5) Smokers or a smoking history within the last 6 months. (The cotinine test is performed, if necessary)
6) Drug abuse or suspicion of drug abuse (The drug screening test is performed, if necessary)
7) Alcohol drinkers (daily alcohol intake* of 50 g or more).
8) Total bilirubin or direct bilirubin is 1.5 times higher and other liver function tests items are 1.25 times higher than the upper limits of normal at the sites.
9) 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.
10) Participation in a Phase I study of a drug containing a new active ingredient within 4 months prior to study drug administration or another clinical study within 3 months, and being administered the investigational drug (within 1 month prior to study drug administration for a patch test). However, even if the period is longer than these, those who are determined to be not eligible for enrollment in the study in consideration of the characteristics of the previous investigational drug.
11) Those who are determined by the investigator to be not suitable as subjects of the study.
80
1st name | |
Middle name | |
Last name | Shinichi Kawai |
Toho University School of Medicine
Division of Rheumatology, Department of Internal Medicine
6-11-1 Omori-nishi, Ota-ku, Tokyo, Japan
03-3762-4151
1st name | |
Middle name | |
Last name | Shinichi Kawai |
Toho University School of Medicine
Division of Rheumatology, Department of Internal Medicine
6-11-1 Omori-nishi, Ota-ku, Tokyo, Japan
03-3762-4151
skawai@med.toho-u.ac.jp
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
Research Grant from Japanese Ministry of Health, Labor and Welfare
Japan
NO
北里大学臨床薬理研究所(東京都)
2010 | Year | 02 | Month | 01 | Day |
Unpublished
Completed
2010 | Year | 01 | Month | 13 | Day |
2010 | Year | 02 | Month | 01 | Day |
2010 | Year | 01 | Month | 03 | Day |
2012 | Year | 09 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003601
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