KJ-TFC-004 Drug-drug Interaction Study

Phase 1

Completed

• Conditions: Glaucoma; Eye Diseases; Ocular Hypertension
• Interventions: Drug: [A]; Drug: [B]; Drug: [A]+[B](2); Drug: [A]+[B](1)

• Registration Number: NCT02967614
• Lead Sponsor: Kukje Pharma

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

Study Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-12
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-18
• Study Start: 2016-12
• Primary Completion: 2017-12
• Study Completion: 2018-04-01
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
[B]→[A]+[B]	[A]+[B](2)	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
[A]→[A]+[B]	[A]	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
[A]→[A]+[B]	[A]+[B](1)	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]	[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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Clinical Trial Center, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of