Phase I study of KRP-AM1977X (Clinical pharmacological study)
Phase 1
Completed
- Conditions
- Japanese healthy adult male subjects
- Registration Number
- JPRN-jRCT2080225163
- Lead Sponsor
- Kyorin Pharmaceutical Co., Ltd.
- Brief Summary
In a phase I clinical study of KRP-AM1977X in healthy Japanese adult males, the safety of KRP-AM1977X was not significantly affected in a single oral dose study up to 800 mg and in a repeated oral dose study up to 400 mg once daily for 7 days, confirming its tolerability.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 54
Inclusion Criteria
Person with BMI that is more than 18.5 but less than 25.0, etc.
Exclusion Criteria
Drug allergy (including drug allergy to mydriatic agent), food allergy or atopy, and those who have a history of it
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>safety
- Secondary Outcome Measures
Name Time Method pharmacokinetics<br>pharmacokinetics