To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers
Study Details
Study Description
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 |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
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
Primary Outcome Measures
- Cmax of Nebivolol [Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8]
Cmax of Nebivolol
- AUCt of Nebivolol [Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8]
AUCt of Nebivolol
- Cmax of DWN12088 [Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12]
Cmax of DWN12088
- AUCt of DWN12088 [Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12]
AUCt of DWN12088
Eligibility Criteria
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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Inje University Busan Paik Hospital | Busan | Korea, Republic of | 47397 |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
- Principal Investigator: Jong-Lyul Ghim, Busan Paik Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DW_DWN12088104