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OpenTrials
Completed

NCT Number: NCT04888728

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 volunteers

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Inje University Busan Paik Hospital

Busan, 47397, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DWN12088

Drug

Prolyl-tRNA synthetase (PRS) inhibitor

nebivolol

Drug

Nebivolol

paroxetine

Drug

Paroxetine

Primary outcomes

  1. Cmax of Nebivolol

    Time frame: Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8

    Cmax of Nebivolol

  2. AUCt of Nebivolol

    Time frame: Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8

    AUCt of Nebivolol

  3. Cmax of DWN12088

    Time frame: Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12

    Cmax of DWN12088

  4. AUCt of DWN12088

    Time frame: Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12

    AUCt of DWN12088

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 17, 2021
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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