Trial Profile

An Open-Label, Randomized, Two-Treatment, Two-Sequence, Four-Period, Fully Replicated Crossover Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 29 May 2024

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At a glance

28 May 2024 According to Genovate Biotech media release, company announced its plans to submit a New Drug Application (NDA) with the United States Food and Drug Administration (US FDA) for PMR, an investigational once daily extended-release form of cilostazol for the treatment of Intermittent Claudication, in the second half of 2025.
21 Feb 2024 Status changed from active, no longer recruiting to completed.
15 Dec 2023 New trial record

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