To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: DWN12088
* Drug: Pirfenidone
* Drug: Nintedanib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged ≥ 19 and ≤ 55 years at screening Subjects who voluntarily decided to participate in the study and provided written consent to after receiving a detailed explanation on this study and fully understanding the information Exclusion Criteria: Subjects who received another investigational agent in another study (including bioequivalence study) within 180 days prior to the first dose of the IP (The end of prior study participation will be the date of the last dose, and the days will be counted from the next day [1 day].) Female subjects who are pregnant or lactating

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWN12088 and Pirfenidone<br>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 | Drug: DWN12088<br>* Prolyl-tRNA synthetase (PRS) inhibitor<br>Drug: Pirfenidone<br>* Pirfenidone<br>|
| Experimental: DWN12088 and Nintedanib<br>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 | Drug: DWN12088<br>* Prolyl-tRNA synthetase (PRS) inhibitor<br>Drug: Nintedanib<br>* Nintedanib<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |