Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers
Information source: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Ocular Hypertension
Intervention: OPC-1085EL ophthalmic solution (Drug); Carteolol long-acting ophthalmic solution (Drug); Latanoprost ophthalmic solution (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Otsuka Pharmaceutical Co., Ltd.
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Cmax of CarteololCmax of Latanoprost Acid
Secondary outcome: Tmax of CarteololTmax of Latanoprost Acid
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Male.
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
Locations and Contacts
Kansai Region, Japan
Additional Information
Starting date: April 2014
Last updated: April 2, 2015
|