KJ-TFC-004 Drug-drug Interaction Study

NCT ID: NCT02967614

Last Updated: 2018-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-04-01

Brief Summary

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To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy male subjects.

Detailed Description

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Clinical trial to evaluate the influence of drug and drug-drug interactions of Brimonidine and Dorzolamide co-administration on the pharmacokinetics of Brimonidine and pharmacokinetics of Dorzolamide in healthy volunteers

Conditions

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Glaucoma Eye Diseases Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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[A]→[A]+[B]

Period 1 : At each dosing of Treatment A eye drops is administered for 8days

Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 92days

Group Type EXPERIMENTAL

[A]

Intervention Type DRUG

One eye drop(about 40ul) / Day1 \~ Day8 / BID

[A]+[B](1)

Intervention Type DRUG

One eye drop(about 40ul) / Day9 \~ Day100 / BID

[B]→[A]+[B]

Period 1 : At each dosing of Treatment B eye drops is administered for 92days

Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 8days

Group Type EXPERIMENTAL

[B]

Intervention Type DRUG

One eye drop(about 40ul) / Day1 \~ Day92 / BID

[A]+[B](2)

Intervention Type DRUG

One eye drop(about 40ul) / Day93 \~ Day100 / BID

Interventions

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[A]

One eye drop(about 40ul) / Day1 \~ Day8 / BID

Intervention Type DRUG

[B]

One eye drop(about 40ul) / Day1 \~ Day92 / BID

Intervention Type DRUG

[A]+[B](1)

One eye drop(about 40ul) / Day9 \~ Day100 / BID

Intervention Type DRUG

[A]+[B](2)

One eye drop(about 40ul) / Day93 \~ Day100 / BID

Intervention Type DRUG

Other Intervention Names

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Brimonidine , Timolol Dorzolamide Brimonidine , Timolol , Dorzolamide Brimonidine , Timolol , Dorzolamide

Eligibility Criteria

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Inclusion Criteria

* Healthy male adults aged between 19 and 50 during screening period
* BMI more than 18kg / m2 and less than 30kg / m2 and weight more than 55kg
* Signed the informed consent form prior to study participation.

Exclusion Criteria

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kukje Pharma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung-sang Yu, Ph.d., M.B.A

Role: PRINCIPAL_INVESTIGATOR

Clinical Trial Center, Seoul National University Hospital

Locations

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Clinical Trial Center, Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KJ-TFC-004

Identifier Type: -

Identifier Source: org_study_id

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