A single-center, randomized, active-controlled study to determine the pharmacokinetics of OPC-1085EL ophthalmic solution in healthy adult male subjects (Phase 1 study)

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222439

Enrollment

Registered

2014-03-26

Start date

2014-03-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult male

Interventions

investigational material(s) Generic name etc : OPC-1085EL ophthalmic solution INN of investigational material : Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Plasma concentration of carteolol and latanoprost acid, pharmacokinetic parameters	—

Secondary

Measure	Time frame
Safety	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026