A Study to Assess the Effect of HRS-1301 on the Pharmacokinetics of Midazolam and Atorvastatin in Healthy Participants

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Primary and study completion dates changed from estimate of Aug 2026 to Aug 24, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 6 of 15 entries
    • Site details revised
  2. Recruitment opened
    • Start date changed from estimate of Jun 2026 to Jun 8, 2026
    • Site details revised
    v2
  3. 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase I study in healthy participants aims to assess the pharmacokinetics of midazolam and atorvastatin when administered alone and in combination with HRS-1301, and to assess the safety of HRS-1301 when administered alone and in combination with midazolam or atorvastatin.
Trial Details
NCT Number NCT07608705
Lead Sponsor Shandong Suncadia Medicine Co., Ltd.
Conditions
(from sponsor)		 Hyperlipidemias
Related terms Hyperlipidemias
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov