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To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers

An Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Male Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04888728
Enrollment
24
Registered
2021-05-17
Start date
2021-06-30
Completion date
2021-07-27
Last updated
2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

Brief summary

An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and nebivolol or Paroxetine in healthy volunteers

Interventions

DRUGDWN12088

Prolyl-tRNA synthetase (PRS) inhibitor

DRUGNebivolol

Nebivolol

DRUGParoxetine

Paroxetine

Sponsors

Daewoong Pharmaceutical Co. LTD.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy male adults aged ≥ 20 and ≤ 55 years at screening * Subjects who voluntarily decided to participate in the study and provided written consent to follow study compliance requirements after receiving a detailed explanation on this study and fully understanding the information

Exclusion criteria

* Subjects unable to have the standard meal provided at the study site * Subjects who took (the day of taking the last dose) another investigational or bioequivalence study product within 180 days prior to the first dose

Design outcomes

Primary

MeasureTime frameDescription
Cmax of NebivololDay 1, Day 2, Day 3, Day 6, Day 7, and Day 8Cmax of Nebivolol
AUCt of NebivololDay 1, Day 2, Day 3, Day 6, Day 7, and Day 8AUCt of Nebivolol
Cmax of DWN12088Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12Cmax of DWN12088
AUCt of DWN12088Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12AUCt of DWN12088

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026