Back to resultsKJ-TFC-004 Drug-drug Interaction Study
Primary Purpose
Glaucoma, Eye Diseases, Ocular Hypertension
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
[A]
[B]
[A]+[B](1)
[A]+[B](2)
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility 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.
Sites / Locations
- Clinical Trial Center, Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
[A]→[A]+[B]
[B]→[A]+[B]
Arm Description
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
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
Outcomes
Primary Outcome Measures
Plasma concentration of Brimonidine and Dorzolamide
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
Trough concentration of Dorzolamide and N-Desethyl-Dorzloamide
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02967614
Brief Title
KJ-TFC-004 Drug-drug Interaction Study
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
April 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kukje Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy male subjects.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Eye Diseases, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[A]→[A]+[B]
Arm Type
Experimental
Arm Description
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
Arm Title
[B]→[A]+[B]
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
[A]
Other Intervention Name(s)
Brimonidine , Timolol
Intervention Description
One eye drop(about 40ul) / Day1 ~ Day8 / BID
Intervention Type
Drug
Intervention Name(s)
[B]
Other Intervention Name(s)
Dorzolamide
Intervention Description
One eye drop(about 40ul) / Day1 ~ Day92 / BID
Intervention Type
Drug
Intervention Name(s)
[A]+[B](1)
Other Intervention Name(s)
Brimonidine , Timolol , Dorzolamide
Intervention Description
One eye drop(about 40ul) / Day9 ~ Day100 / BID
Intervention Type
Drug
Intervention Name(s)
[A]+[B](2)
Other Intervention Name(s)
Brimonidine , Timolol , Dorzolamide
Intervention Description
One eye drop(about 40ul) / Day93 ~ Day100 / BID
Primary Outcome Measure Information:
Title
Plasma concentration of Brimonidine and Dorzolamide
Description
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)
Time Frame
pre- and post dose of Brimonidine and Dorzolamide administration]
Secondary Outcome Measure Information:
Title
Trough concentration of Dorzolamide and N-Desethyl-Dorzloamide
Description
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)
Time Frame
pre- and post dose of Dorzolamide and Dorzloamide administration]
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-sang Yu, Ph.d., M.B.A
Organizational Affiliation
Clinical Trial Center, Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trial Center, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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KJ-TFC-004 Drug-drug Interaction Study
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