Healthy adult male subjects
Conditions
Interventions
Single administration of 400 mg tablet of moxifloxacin
Sponsors
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
Eligibility
Sex/Gender
Male
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of moxifloxacin | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
Japan,Asia(except Japan),North America
Contacts
Public ContactShinichi Kawai
Toho University School of Medicine Division of Rheumatology, Department of Internal Medicine
Outcome results
None listed