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OpenTrials
Completed

NCT Number: NCT02108288

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kansai Region, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPC-1085EL ophthalmic solution

Drug

Carteolol long-acting ophthalmic solution

Drug

Latanoprost ophthalmic solution

Drug

Primary outcomes

  1. Cmax of Carteolol

    Time frame: Day 1 and Day 7

  2. Cmax of Latanoprost Acid

    Time frame: Day 1 and Day 7

Secondary outcomes

  1. Tmax of Carteolol

    Time frame: Day 1 and Day 7

  2. Tmax of Latanoprost Acid

    Time frame: Day 1 and Day 7

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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