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A three-way crossover, Phase III, pharmacokinetic study evaluating the bioavailability of RHB-105 actives versus the comparator in healthy volunteers.

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Trial Profile

A three-way crossover, Phase III, pharmacokinetic study evaluating the bioavailability of RHB-105 actives versus the comparator in healthy volunteers.

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Mar 2025

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At a glance

Most Recent Events

  • 18 Mar 2025 According to a RedHill Biopharma media release, the company announced its plan to submit a UK Marketing Authorisation Application (MAA) for Talicia for treatment of H. pylori infection under the Medicines and Healthcare products Regulatory Agency's (MHRA) International Recognition Procedure (IRP). Utilizing the U.S. Food and Drug Administration (FDA) approval of Talicia as reference, potential UK approval could be received as early as the 4Q of 2025.
  • 01 Aug 2023 According to a RedHill Biopharma media release, Gaelan Medical received marketing approval from the United Arab Emirates (UAE) Ministry of Health for Talicia (omeprazole magnesium, amoxicillin and rifabutin).
  • 04 Nov 2019 According to an RedHill Biopharma media release, the company will host an Investor and Analyst day on November 22, 2019 in New York to review launch plans for Talicia and provide an overview of the Company's commercial operations.

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