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A Phase IIB, Open-Label, Randomized Controlled Dose Ranging Multi-Center Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Exposure-Response Relationship of Different Doses of Sutezolid in Combination With Bedaquiline, Delamanid and Moxifloxacin in Adult Subjects With Newly Diagnosed, Uncomplicated, Smear-Positive, Drug-sensitive Pulmonary Tuberculosis

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Trial Profile

A Phase IIB, Open-Label, Randomized Controlled Dose Ranging Multi-Center Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Exposure-Response Relationship of Different Doses of Sutezolid in Combination With Bedaquiline, Delamanid and Moxifloxacin in Adult Subjects With Newly Diagnosed, Uncomplicated, Smear-Positive, Drug-sensitive Pulmonary Tuberculosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 May 2023

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At a glance

  • Drugs Sutezolid (Primary) ; Bedaquiline; Delamanid; Midazolam; Moxifloxacin
  • Indications Pulmonary tuberculosis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms SUDOCU

    • Most Recent Events

    • 28 Apr 2023 Status changed from active, no longer recruiting to completed.
    • 10 Aug 2022 Planned End Date changed from 30 Aug 2022 to 30 Oct 2022.
    • 10 Aug 2022 Planned primary completion date changed from 30 Apr 2022 to 30 Oct 2022.

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