KJ-TFC-004 Drug-drug Interaction Study

Kukje Pharma

Status and phase: Completed; Phase 1

Conditions: Glaucoma; Ocular Hypertension; Eye Diseases

Treatments: Drug: [A]; Drug: [B]; Drug: [A]+[B](2); Drug: [A]+[B](1)

Study type: Interventional

Funder types: Other

Identifiers

NCT02967614

KJ-TFC-004

Details and patient eligibility

About

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

Full 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

Enrollment: 32 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

[A]→[A]+[B]

Experimental group

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

Treatment:

Drug: [A]

Drug: [A]+[B](1)

[B]→[A]+[B]

Experimental group

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

Treatment:

Drug: [B]

Drug: [A]+[B](2)