Skip to main content
OpenTrials
Completed

NCT Number: NCT02967614

KJ-TFC-004 Drug-drug Interaction Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Center, Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

[A]

Drug

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

Other names: Brimonidine , Timolol

[B]

Drug

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

Other names: Dorzolamide

[A]+[B](1)

Drug

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

Other names: Brimonidine , Timolol , Dorzolamide

[A]+[B](2)

Drug

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

Other names: Brimonidine , Timolol , Dorzolamide

Primary outcomes

  1. Plasma concentration of Brimonidine and Dorzolamide

    Time frame: pre- and post dose of Brimonidine and Dorzolamide administration]

    Group 1 Brimonidine Period 1 : 1d 0h,7d 0h,7d 12h,8d 0h(pre-dose), 8d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 15 Point)

    Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h, 100d 0h(pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 21Point)

    Dorzolamide

    Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h,100d 0h (pre-dose), 100d 0.25,0.5,0.75,1,1.5,2,2.5,3,4,8,12 h post-dose (Total 21Point)

    Group 2 Brimonidine Period 2 : 93d 0h,99d 0h,99d 12h,100d 0h(pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5,2,2.5,3,4,8,12h post-dose (Total 15Point)

    Dorzolamide Period 1 : 1d 0h, 15d 0h, 29d 0h, 43d 0h, 57d 0h, 71d 0h, 85d 0h, 91d 0h, 91d 12h, 92d 0h (pre-dose), 92d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 21Point)

    Period 2 : 93d 0h, 99d 0h, 99d 12h, 100d 0h (pre-dose), 100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 15Point)

Secondary outcomes

  1. Trough concentration of Dorzolamide and N-Desethyl-Dorzloamide

    Time frame: pre- and post dose of Dorzolamide and Dorzloamide administration]

    Group 1 Brimonidine Period 1 : 1d 0h,7d 0h,7d 12h 8d 0h (pre-dose),8d 0.25,0.5,0.75,1,1.5,2,2.5,3, 4,8,12 h post-dose (Total 15Point)

    Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h,100d 0h (pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12h post-dose (Total 21Point)

    Dorzolamide

    Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h,100d 0h (pre-dose), 100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12h post-dose (Total 21Point)

    Group 2 Brimonidine Period 2 : 93d 0h,99d 0h,99d 12h,100d 0h (pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5,2,2.5,3,4,8,12h post-dose (Total 15Point)

    Dorzolamide Period 1 : 1d 0h,15d 0h,29d 0h,43d 0h,57d 0h,71d 0h,85d 0h,91d 0h, 91d 12h,92d 0h(pre-dose), 92d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12h post-dose (Total 21Point)

    Period 1 : 93d 0h,99d 0h,99d 12h,100d 0h (pre-dose), 100d 0.25, 0.5, 0.75, 1, 1.5,2,2.5,3,4,8,12h post-dose (Total 15Point)

Sponsors and collaborators

Lead sponsor

Kukje Pharma

Other

Registry information

Official study title

A Randomized, Open-label, 2-period, Parallel Group, Multiple-dose Study to Evaluate the Drug-drugs Interaction Between Dorzolamide and Brimonidine in Healthy Korean Male Volunteers

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Nov 18, 2016
Registry last updated
Apr 11, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.