Trial | NCT02967614  Report issue

Title

KJ-TFC-004 Drug-drug Interaction Study
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    32
To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy male subjects.
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
Study Started
Dec 31
2016
Primary Completion
Dec 31
2017
Study Completion
Apr 01
2018
Last Update
Apr 11
2018

Drug [A]

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

  • Other names: Brimonidine , Timolol

Drug [B]

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

  • Other names: Dorzolamide

Drug [A]+[B](1)

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

  • Other names: Brimonidine , Timolol , Dorzolamide

Drug [A]+[B](2)

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

  • Other names: Brimonidine , Timolol , Dorzolamide

[A]→[A]+[B] Experimental

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

[B]→[A]+[B] Experimental

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

Criteria 

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.
No Results Posted