Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Completed without a posted recruiting period Show 4 more changesShow less
    • Primary and study completion dates changed from estimate of Aug 10, 2026 to Aug 3, 2026
    • Interventions: Chiglitazar tablet, dose 1 (Drug), Chiglitazar tablet, dose 2 (Drug), Chiglitazar/Metformin extended-release fixed-dose combination tablet… to Chiglitazar tablet, dose 1 (Drug), Chiglitazar tablet, dose 2 (Drug), Chiglitazar/Metformin extended-release fixed-dose combination tablet…
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 3 of 5 entries
  2. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a single-center, randomized, open-label, two-period, two-sequence crossover bioequivalence study under fed conditions. The primary objective is to evaluate the bioequivalence of a single oral dose of the test formulation compared with the reference formulation in the fed state.
Trial Details
NCT Number NCT07519265
Lead Sponsor Chipscreen Biosciences, Ltd.
Conditions
(from sponsor)		 T2DM (Type 2 Diabetes Mellitus)
Related terms Diabetes Mellitus, Type 2
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov