|
Main
|
|
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: |
|
|
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: Nebivolol
|
|
Drug: Paroxetine
|
|
Drug: DWN12088
|
|
Primary Outcome(s)
|
|
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]
|
|
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]
|
|
Secondary ID(s)
|
|
DW_DWN12088104
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|