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Trial record 51 of 152 for:    Brimonidine

KJ-TFC-004 Drug-drug Interaction Study

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ClinicalTrials.gov Identifier: NCT02967614
Recruitment Status : Completed
First Posted : November 18, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Kukje Pharma

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

Condition or disease Intervention/treatment Phase
Glaucoma Eye Diseases Ocular Hypertension Drug: [A] Drug: [B] Drug: [A]+[B](1) Drug: [A]+[B](2) 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

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Study Type : Interventional  (Clinical Trial)
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 : December 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Dorzolamide

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 Name: Brimonidine , Timolol

Drug: [A]+[B](1)
One eye drop(about 40ul) / Day9 ~ Day100 / BID
Other Name: 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 Name: Dorzolamide

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




Primary Outcome Measures :
  1. Plasma concentration of Brimonidine and Dorzolamide [ Time Frame: 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 [ Time Frame: 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)




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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967614


Locations
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Korea, Republic of
Clinical Trial Center, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Kukje Pharma
Investigators
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Principal Investigator: Kyung-sang Yu, Ph.d., M.B.A Clinical Trial Center, Seoul National University Hospital

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Responsible Party: Kukje Pharma
ClinicalTrials.gov Identifier: NCT02967614     History of Changes
Other Study ID Numbers: KJ-TFC-004
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Brimonidine Tartrate
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Timolol
Dorzolamide
Pharmaceutical Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors