A Study of BGM0504 Tablets in Healthy Chinese Subjects

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 3 entries Show 5 more changesShow less
    • Trial completed
    • Primary completion date changed from estimate of Sep 30, 2026 to Aug 31, 2026
    • Eligibility criteria expanded, about 19 words
    • Site details revised
    • Collaborators shortened, about 5 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
A randomized, open-label, multiple-dose study to evaluate the effects of high-fat meals and different administration conditions (including water intake and fasting time) on the pharmacokinetics of BGM0504 tablets at a dose of 20mg in healthy Chinese participants and to assess its safety and tolerability.
Trial Details
NCT Number NCT07566572
Lead Sponsor BrightGene Bio-Medical Technology Co., Ltd.
Conditions
(from sponsor)		 Chinese Healthy Volunteers
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov