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NCT04888728 Clinical Trial

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

Idiopathic Pulmonary Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04888728
Other study ID # DW_DWN12088104
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 30, 2021
Est. completion date July 27, 2021

Study information
Verified date August 2021
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date July 27, 2021
Est. primary completion date July 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DWN12088
Prolyl-tRNA synthetase (PRS) inhibitor
• Nebivolol
Nebivolol
• Paroxetine
Paroxetine

Locations
Country Name City State
Korea, Republic of Inje University Busan Paik Hospital Busan

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax of Nebivolol Cmax of Nebivolol Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8
Primary AUCt of Nebivolol AUCt of Nebivolol Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8
Primary Cmax of DWN12088 Cmax of DWN12088 Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12
Primary AUCt of DWN12088 AUCt of DWN12088 Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12
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