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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 August 2021
Main ID:  NCT04888728
Date of registration: 28/04/2021
Prospective Registration: Yes
Primary sponsor: Daewoong Pharmaceutical Co. LTD.
Public title: To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers
Scientific 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
Date of first enrolment: June 30, 2021
Target sample size: 24
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT04888728
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
Korea, Republic of
Contacts
Name:     Jong-Lyul Ghim
Address: 
Telephone:
Email:
Affiliation:  Busan Paik Hospital
Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 55 Years
Gender: Male
Health Condition(s) or Problem(s) studied
Idiopathic Pulmonary Fibrosis
Intervention(s)
Drug: DWN12088
Drug: Nebivolol
Drug: Paroxetine
Primary Outcome(s)
AUCt of DWN12088 [Time Frame: Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12]
Cmax of Nebivolol [Time Frame: Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8]
AUCt of Nebivolol [Time Frame: Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8]
Cmax of DWN12088 [Time Frame: Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12]
Secondary Outcome(s)
Secondary ID(s)
DW_DWN12088104
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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