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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Oral Doses of BI 1323495 Versus Placebo in Healthy Subjects, Including an Investigation of Drug-drug Interaction With Microdose Midazolam (Double-blind, Randomised, Placebo-controlled [Within Dose Groups] Trial)

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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Oral Doses of BI 1323495 Versus Placebo in Healthy Subjects, Including an Investigation of Drug-drug Interaction With Microdose Midazolam (Double-blind, Randomised, Placebo-controlled [Within Dose Groups] Trial)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Feb 2024

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At a glance

  • Drugs BI 1323495 (Primary) ; Midazolam
  • Indications Chronic obstructive pulmonary disease; Cystic fibrosis
  • Focus Adverse reactions
  • Sponsors Boehringer Ingelheim

    • Most Recent Events

    • 10 Mar 2021 Status changed from recruiting to completed.
    • 03 Mar 2021 Planned number of patients changed from 88 to 87.
    • 28 Jan 2021 Planned End Date changed from 12 Feb 2021 to 4 Mar 2021.

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