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To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04888728
Recruitment Status : Completed
First Posted : May 17, 2021
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Study Description
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Brief Summary:
An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and nebivolol or Paroxetine in healthy volunteers

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: DWN12088 Drug: Nebivolol Drug: Paroxetine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between "DWN12088" and "Nebivolol" or "Paroxetine" in Healthy Male Volunteers
Actual Study Start Date : June 30, 2021
Actual Primary Completion Date : July 12, 2021
Actual Study Completion Date : July 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arms and Interventions
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Arm Intervention/treatment
Experimental: DWN12088 and Nebivolol
Period 1 - Nebivolol A mg, Tablet, oral, once daily, Period 2 - DWN12088 X mg, Tablet, oral, twice daily, Period 3 - 1) Nebivolol A mg, Tablet, oral, once daily & DWN12088 X mg, Tablet, oral, twice daily, 2) DWN12088 X mg, Tablet, oral, once daily
 Drug: DWN12088
Prolyl-tRNA synthetase (PRS) inhibitor

Drug: Nebivolol
Nebivolol
Experimental: DWN12088 and Paroxetine
Period 1 - DWN12088 X mg, Tablet, oral, once daily , Period 2 - Paroxetine B mg, Tablet, oral, once daily, Period 3 - 1) DWN12088 X mg, Tablet, oral, once daily & Paroxetine B mg, Tablet, oral, once daily, 2) Paroxetine B mg, Tablet, oral, once daily
 Drug: DWN12088
Prolyl-tRNA synthetase (PRS) inhibitor

Drug: Paroxetine
Paroxetine


Outcome Measures
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Primary Outcome Measures :
  1. Cmax of Nebivolol [ Time Frame: Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8 ]
    Cmax of Nebivolol

  2. AUCt of Nebivolol [ Time Frame: Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8 ]
    AUCt of Nebivolol

  3. Cmax of DWN12088 [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12 ]
    Cmax of DWN12088

  4. AUCt of DWN12088 [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12 ]
    AUCt of DWN12088


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male adults aged ≥ 20 and ≤ 55 years at screening
  • Subjects who voluntarily decided to participate in the study and provided written consent to follow study compliance requirements after receiving a detailed explanation on this study and fully understanding the information

Exclusion Criteria:

  • Subjects unable to have the standard meal provided at the study site
  • Subjects who took (the day of taking the last dose) another investigational or bioequivalence study product within 180 days prior to the first dose
Contacts and Locations
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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): NCT04888728


Locations
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Korea, Republic of
Inje University Busan Paik Hospital
Busan, Korea, Republic of, 47397
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
Investigators
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Principal Investigator: Jong-Lyul Ghim Busan Paik Hospital
More Information
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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT04888728    
Other Study ID Numbers: DW_DWN12088104
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Lung Diseases
Respiratory Tract Diseases
Nebivolol
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
 Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents