A Pharmacokinetic Study to Evaluate the Bioequivalence of a Test Formulation Compared to an Equivalent Dose of a Reference Drug Product

  • STATUS
    Not Recruiting
  • participants needed
    14
  • sponsor
    isRed Pharma & Biotech Research Corporation
Updated on 21 January 2021

Summary

To assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in healthy volunteers who reside in Taiwan.

Description

This study is designed to assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in healthy volunteers who reside in Taiwan. Bioequivalence will be assumed if the 90% confidence interval of the AUC0-t, AUC0-inf and Cmax ratio are within the 80-125% interval for log-transformed values.

Details
Condition Healthy Adult Subjects
Treatment Nexium powder for injection and infusion 40 mg, Esomelone Powder for Solution for Injection / Infusion 40 mg
Clinical Study IdentifierNCT02444507
SponsorisRed Pharma & Biotech Research Corporation
Last Modified on21 January 2021

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