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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Nebivolol; Drug: DWN12088; Drug: Paroxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04888728

DW_DWN12088104

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

DWN12088 and Nebivolol

Experimental group

Description:

Period 1 - Nebivolol A mg, Tablet, oral, once daily, Period 2 - DWN12088 X mg, Tablet, oral, twice daily, Period 3 - 1) Nebivolol A mg, Tablet, oral, once daily \& DWN12088 X mg, Tablet, oral, twice daily, 2) DWN12088 X mg, Tablet, oral, once daily

Treatment:

Drug: DWN12088

Drug: Nebivolol

DWN12088 and Paroxetine

Experimental group

Description:

Period 1 - DWN12088 X mg, Tablet, oral, once daily , Period 2 - Paroxetine B mg, Tablet, oral, once daily, Period 3 - 1) DWN12088 X mg, Tablet, oral, once daily \& Paroxetine B mg, Tablet, oral, once daily, 2) Paroxetine B mg, Tablet, oral, once daily

Treatment:

Drug: DWN12088

Drug: Paroxetine