To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers
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
1 other identifier
interventional
24
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2021
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2021
CompletedFirst Posted
Study publicly available on registry
May 17, 2021
CompletedStudy Start
First participant enrolled
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2021
CompletedAugust 4, 2021
August 1, 2021
12 days
April 28, 2021
August 3, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
Cmax of Nebivolol
Cmax of Nebivolol
Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8
AUCt of Nebivolol
AUCt of Nebivolol
Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8
Cmax of DWN12088
Cmax of DWN12088
Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12
AUCt of DWN12088
AUCt of DWN12088
Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12
Study Arms (2)
DWN12088 and Nebivolol
EXPERIMENTALPeriod 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
DWN12088 and Paroxetine
EXPERIMENTALPeriod 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inje University Busan Paik Hospital
Busan, 47397, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jong-Lyul Ghim
Busan Paik Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2021
First Posted
May 17, 2021
Study Start
June 30, 2021
Primary Completion
July 12, 2021
Study Completion
July 27, 2021
Last Updated
August 4, 2021
Record last verified: 2021-08