Phase 1
N=30
Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers
Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02108288 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Cmax of Carteolol — 0.8558; 0.9984; 1.174; 1.627 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- OPC-1085EL ophthalmic solution (Drug); Carteolol long-acting ophthalmic solution (Drug); Latanoprost ophthalmic solution (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Male
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of Carteolol |
0.8558; 0.9984; 1.174; 1.627 | — |
| PRIMARY Cmax of Latanoprost Acid |
19.77; 21.22; 18.47; 17.48 | — |
| SECONDARY Tmax of Carteolol |
0.25; 0.25; 0.25; 0.38 | — |
| SECONDARY Tmax of Latanoprost Acid |
10; 10; 5; 10 | — |
Summary
OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.
Eligibility Criteria
Inclusion Criteria
- 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: <10 or ≥22 mmHg
Data sourced from ClinicalTrials.gov (NCT02108288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.