ascufloxacin hydrochloride clinical study

Phase 4

• Conditions: Pneumonia

• Registration Number: JPRN-jRCTs061200015
• Lead Sponsor: Chikumi Hiroki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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
4) Patient with symptoms suspected of respiratory infection
5) Patient who do not have a tendency to constipate and have a habit of daily bowel movements
6) Patient who can defecate before administration of study drug

Exclusion Criteria

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
2) Patient who are pregnant or nursing or who desire to become pregnant during the study period. Patient who is unwilling to agree to practice appropriate contraception during the study period
3) Lactating female patient
4) Patinet who have unsuitable medical history as a study subject or a history of abdominal surgery that may affect drug absorption
5) Patient who have drunk excessively or cannot keep drinking during the study period
6) Patient who received antibacterial drugs within 28 days before study drug administration or who schedule to administer antibacterial drugs during the study period
7) Subject who received lactic acid bacteria beverage within 7 days before study drug administration
8) Subject who have participated in other clinical trials or clinical researches of unapproved drugs within 3 months before registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified