NCT02967614

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Kukje Pharma · Academic / Other
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Glaucoma
• Eye Diseases
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	[A]	One eye drop(about 40ul) / Day1 \~ Day8 / BID
DRUG	[B]	One eye drop(about 40ul) / Day1 \~ Day92 / BID
DRUG	[A]+[B](1)	One eye drop(about 40ul) / Day9 \~ Day100 / BID
DRUG	[A]+[B](2)	One eye drop(about 40ul) / Day93 \~ Day100 / BID

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-12-01
• Completion: 2018-04-01
• First posted: 2016-11-18
• Last updated: 2018-04-11

Locations

1 site across 1 country: South Korea