Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers

April 2, 2015 updated by: Otsuka Pharmaceutical Co., Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kansai Region, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: OPC-1085EL ophthalmic solution
Once daily
Drug: OPC-1085EL ophthalmic solution
ACTIVE_COMPARATOR: Carteolol long-acting ophthalmic solution
Once daily
Drug: Carteolol long-acting ophthalmic solution
ACTIVE_COMPARATOR: Latanoprost ophthalmic solution
Once daily
Drug: Latanoprost ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax of Carteolol
Time Frame: Day 1 and Day 7
Day 1 and Day 7
Cmax of Latanoprost Acid
Time Frame: Day 1 and Day 7
Day 1 and Day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Tmax of Carteolol
Time Frame: Day 1 and Day 7
Day 1 and Day 7
Tmax of Latanoprost Acid
Time Frame: Day 1 and Day 7
Day 1 and Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

April 6, 2014

First Posted (ESTIMATE)

April 9, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1085EL-13-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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