Phase I study of KRP-AM1977Y
Phase 1
Completed
- Conditions
- -
- Registration Number
- JPRN-jRCT2080225244
- Lead Sponsor
- Kyorin Pharmaceutical Co., Ltd.
- Brief Summary
The plasma concentration trough values of AM-1977 and AM2012-008 when KRP-AM1977Y 150mg (300mg on the first day) was administered for 7 days ranged from 0.771 to 0.915 and 0.0789 to 0.0887ug/mL, respectively. On day 7, Cmax of AM-1977 and AM2012-008 was 2.92, 0.124ug/mL and AUC was 35.4, 2.48ug*h/mL, respectively. The urinary excretion rates of AM-1977 and AM2012-008 were 17.5%, 27.4%. No clinically significant safety finding was reported.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 18
Inclusion Criteria
Person with BMI that is more than 18.5 but less than 25.0, etc.
Exclusion Criteria
Have a history of allergy or severe side effects to quinolone antibiotics.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics<br>pharmacokinetics
- Secondary Outcome Measures
Name Time Method safety<br>safety