Trial Profile

Phase I Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Multiple i.v. Doses of N-acetylcysteine (NAC) in Chinese Healthy Volunteers

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 30 Jun 2025

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At a glance

24 Jun 2025 According to Zambon Biotech SA media release, company announced the approval by Chinese regulatory authorities and the launch on the Chinese market of the intravenous (IV) formulation of Fluimucil (N-acetylcysteine). The approval is based on locally conducted Phase 1 and a Phase 3 clinical trial that confirmed the drug's safety, tolerability, and efficacy profile.
03 Dec 2019 Status changed from not yet recruiting to recruiting.
25 Sep 2019 Planned End Date changed from 10 Sep 2019 to 22 May 2020.

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