Multicenter study to evaluate the influence for intestinal flora of multiple dose of Lascufloxacin hydrochloride

Chikumi Hiroki0 sites20 target enrollmentSeptember 28, 2020

Overview

No summary available.

Registry

who.int

Start Date

September 28, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Chikumi Hiroki

•Healthy male volunteer
•1\) 20\-45 years old healthy Japanese male
•2\) BMI of 18\.5\-25\.0
•3\) Subject who was judged healthy by investigator at screening and hospital admission visit
•4\) Subject who do not have a tendency to constipate and have a habit of daily bowel movements
•5\) Subject who can defecate before administration of study drug
•Pneumonia patient
•1\) 20 or above years old Japanese
•2\) Patients who were determined to administer Lascufloxacin hydrochloride by investigator
•3\) Patient with a clear infiltrative shadow on the chest X\-ray or CT image taken within 48 hours before the start of study drug administration

•Healthy male volunteer
•1\) Subject with a history of hypersensitivity or serious adverse effects to quinolone antibiotics
•2\) Subject who have unsuitable medical history as a study subject or a history of abdominal surgery that may affect drug absorption
•3\) Subject who have drunk excessively or cannot keep drinking during the study period
•4\) Subject who received antibacterial drugs within 28 days before study drug administration or who schedule to administer antibacterial drugs during the study period
•5\) Subject who received lactic acid bacteria beverage within 7 days before study drug administration
•6\) Subject who have a positive immunoserologic test at the screening test
•7\) Subject who have participated in other clinical trials or clinical researches of unapproved drugs within 3 months before registration
•Pneumonia patient
•1\) Patient with a history of hypersensitivity or serious adverse effects to quinolone antibiotics