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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 Carteolol

Cmax of Latanoprost Acid

Secondary outcome:

Tmax of Carteolol

Tmax 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

Page last updated: August 23, 2015

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