Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
An Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between "DWN12088" and "Pirfenidone" or "Nintedanib" in Healthy Volunteers
Verified date | September 2021 |
Source | Daewoong Pharmaceutical Co. LTD. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and Pirfenidone or Nintedanib in healthy volunteers
Status | Completed |
Enrollment | 48 |
Est. completion date | August 18, 2021 |
Est. primary completion date | August 2, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Cha Unitersity Bundang Medical Center | Seongnam-si |
Lead Sponsor | Collaborator |
---|---|
Daewoong Pharmaceutical Co. LTD. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cmax of Pirfenidone and DWN12088 | Cmax of Pirfenidone and DWN12088 | 0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour | |
Primary | AUC of Pirfenidone and DWN12088 | AUC of Pirfenidone and DWN12088 | 0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour | |
Primary | Cmax of Nintedanib and DWN12088 | Cmax of Nintedanib and DWN12088 | 0hour (pre-dose), 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 10hour, 12hour | |
Primary | 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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