Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

StatusCompleted
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Completed without a posted recruiting period Show 5 more changesShow less
    • Primary completion date changed from estimate of Jun 29, 2026 to May 26, 2026
    • Study completion date changed from estimate of Jun 29, 2026 to May 28, 2026
    • Start date changed from estimate of May 27, 2026 to May 15, 2026
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 3 of 6 entries
  2. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a pilot bioequivalence study. It is a randomized, open-label, single-dose, crossover study. The primary objective of this study is to preliminarily evaluate the pharmacokinetic parameters and their variability of the test formulation versus the reference formulation following a single oral dose under fed conditions.
Trial Details
NCT Number NCT07412015
Lead Sponsor Chipscreen Biosciences, Ltd.
Conditions
(from sponsor)		 T2DM (Type 2 Diabetes Mellitus)
Related terms Diabetes Mellitus, Type 2
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov