Status:
COMPLETED
To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
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
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04888715
Start Date
July 23 2021
End Date
August 18 2021
Last Update
September 23 2021
Active Locations (1)
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1
Cha Unitersity Bundang Medical Center
Seongnam-si, South Korea, 13520