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KJ-TFC-004 Drug-drug Interaction Study

Sponsor
Kukje Pharma (Other)
Overall Status
Completed
CT.gov ID
NCT02967614
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
16
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: [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

Drug: [A]
One eye drop(about 40ul) / Day1 ~ Day8 / BID
Other Names:
  • Brimonidine , Timolol

    • Drug: [A]+[B](1)
    One eye drop(about 40ul) / Day9 ~ Day100 / BID
    Other Names:
  • Brimonidine , Timolol , Dorzolamide

    		•
    Experimental: [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

    Drug: [B]
    One eye drop(about 40ul) / Day1 ~ Day92 / BID
    Other Names:
  • Dorzolamide

    • Drug: [A]+[B](2)
    One eye drop(about 40ul) / Day93 ~ Day100 / BID
    Other Names:
  • Brimonidine , Timolol , Dorzolamide

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma concentration of Brimonidine and Dorzolamide [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 Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Trial Center, Seoul National University Hospital Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Kukje Pharma

    Investigators

    • Principal Investigator: Kyung-sang Yu, Ph.d., M.B.A, Clinical Trial Center, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kukje Pharma
    ClinicalTrials.gov Identifier:
    NCT02967614
    Other Study ID Numbers:
    • KJ-TFC-004
    First Posted:
    Nov 18, 2016
    Last Update Posted:
    Apr 11, 2018
    Last Verified:
    Nov 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Ocular Hypertension
    Eye Diseases
    Timolol
    Brimonidine Tartrate
    Dorzolamide

    Study Results

    No Results Posted as of Apr 11, 2018