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

Phase 1

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: DWN12088; Drug: Paroxetine; Drug: Nebivolol

• Registration Number: NCT04888728
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-17
• Study Start: 2021-06-30
• Primary Completion: 2021-07-12
• Study Completion: 2021-07-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWN12088 and Nebivolol	DWN12088	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
DWN12088 and Paroxetine	DWN12088	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
DWN12088 and Paroxetine	Paroxetine	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
DWN12088 and Nebivolol	Nebivolol	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

Primary Outcome Measures

Name	Time	Method
AUCt of DWN12088	Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12	AUCt of DWN12088
Cmax of Nebivolol	Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8	Cmax of Nebivolol
AUCt of Nebivolol	Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8	AUCt of Nebivolol
Cmax of DWN12088	Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12	Cmax of DWN12088

Trial Locations

Locations (1)

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of