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An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and Pirfenidone or Nintedanib in healthy volunteers
This clinical trial is an open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and Pirfenidone or Nintedanib in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWN12088 and Pirfenidone | Experimental | T1 - Pirfenidone A mg, Tablet, oral, once daily, T2 - 1) DWN12088 X mg, Tablet, oral, once daily, 2) DWN12088 X mg, Tablet, oral, twice daily, T3 - DWN12088 X mg, Tablet, oral, once daily+ Pirfenidone A mg, Tablet, oral, once daily |
|
| DWN12088 and Nintedanib | Experimental | T1 - Nintedanib B mg, Tablet, oral, once daily, T2 - DWN12088 X mg, Tablet, oral, twice daily, T3 - DWN12088 X mg, Tablet, oral, once daily+ Nintedanib 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 Pirfenidone and DWN12088 | Cmax of Pirfenidone and DWN12088 | 0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour |
| AUC of Pirfenidone and DWN12088 | AUC of Pirfenidone and DWN12088 | 0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour |
| Cmax of Nintedanib and DWN12088 | Cmax of Nintedanib and DWN12088 | 0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour |
| AUC of Nintedanib and DWN12088 | AUC of Nintedanib and DWN12088 | 0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim | CHA UNITERSITY BUNDANG MEDICAL CENTER | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cha Unitersity Bundang Medical Center | Seongnam-si | 13520 | 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 |
|---|---|
| C093844 | pirfenidone |
| C530716 | nintedanib |
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| Pirfenidone | Drug | Pirfenidone |
|
| Nintedanib | Drug | Nintedanib |
|