Phase I study of KRP-AM1977X (Clinical pharmacological study)

Phase 1

Completed

• Conditions: Patients with having otorhinolaryngological surgery

• Registration Number: JPRN-jRCT2080222747
• Lead Sponsor: Kyorin Pharmaceutical Co.,LTD

Brief Summary

The concentration of AM-1977 in otorhinolaryngologic tissues was higher than that in plasma, indicating good transferability to these tissues. In the safety assessment, no major problem was observed in KRP-AM1977X.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-09
• Study Completion: 2016-05-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Person with BMI that is more than 18.5 but less than 30.0, etc.

Exclusion Criteria

- Have a history of allergy or severe side effects to quinolone antibiotics.
-Have a presence of severe renal dysfunction or significant hepatic disorder etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified