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An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and nebivolol or Paroxetine in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWN12088 and Nebivolol | Experimental | 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 |
|
| DWN12088 and Paroxetine | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWN12088 | Drug | Prolyl-tRNA synthetase (PRS) inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jong-Lyul Ghim | Busan Paik Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | 47397 | South Korea |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068577 | Nebivolol |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Nebivolol | Drug | Nebivolol |
|
| Paroxetine | Drug | Paroxetine |
|
| D000588 |
| Amines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010880 | Piperidines |