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

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ClinicalTrials.gov Identifier: NCT02108288
Recruitment Status : Completed
First Posted : April 9, 2014
Results First Posted : April 2, 2015
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: OPC-1085EL ophthalmic solution Drug: Carteolol long-acting ophthalmic solution Drug: Latanoprost ophthalmic solution Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : April 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Carteolol

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Cmax of Carteolol [ Time Frame: Day 1 and Day 7 ]
  2. Cmax of Latanoprost Acid [ Time Frame: Day 1 and Day 7 ]

Secondary Outcome Measures :
  1. Tmax of Carteolol [ Time Frame: Day 1 and Day 7 ]
  2. Tmax of Latanoprost Acid [ Time Frame: Day 1 and Day 7 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108288


Locations
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Japan
Kansai Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02108288    
Other Study ID Numbers: 1085EL-13-004
First Posted: April 9, 2014    Key Record Dates
Results First Posted: April 2, 2015
Last Update Posted: April 22, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases
Carteolol
Pharmaceutical Solutions
Latanoprost
Ophthalmic Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents