A single-center, randomized, active-controlled study to determine the pharmacokinetics of OPC-1085EL ophthalmic solution in healthy adult male subjects (Phase 1 study)
Phase 1
- Conditions
- Healthy adult male
- Registration Number
- JPRN-jRCT2080222439
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
BMI{weight(kg)/[height(m)]2} equal to or more than 18.5 and less than 25.0
Subjects who are considered medically healthy per investigator's judgment
Exclusion Criteria
Subjects with ocular conditions as defined by the protocol
Subjects with intraocular pressure: less than 10 or equal to or more than 22 mmHg
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration of carteolol and latanoprost acid, pharmacokinetic parameters
- Secondary Outcome Measures
Name Time Method Safety