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A Randomized, 2-period, 2-treatment, Single-dose, Crossover Study to Assess the Bioequivalence of the Fixed Dose Combination (FDC) of Dapagliflozin 10 mg and Sitagliptin 100 mg, and Dapagliflozin 10 mg and Sitagliptin 100 mg Administered as Individual Tablets in Healthy Subjects

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Trial Profile

A Randomized, 2-period, 2-treatment, Single-dose, Crossover Study to Assess the Bioequivalence of the Fixed Dose Combination (FDC) of Dapagliflozin 10 mg and Sitagliptin 100 mg, and Dapagliflozin 10 mg and Sitagliptin 100 mg Administered as Individual Tablets in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Nov 2023

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At a glance

  • Drugs Dapagliflozin/sitagliptin (Primary) ; Dapagliflozin; Sitagliptin
  • Indications Type 2 diabetes mellitus
  • Focus Pharmacokinetics
  • Sponsors AstraZeneca

Most Recent Events

  • 12 Sep 2023 Primary endpoint has been met. (Maximum observed plasma (peak) drug concentration (Cmax), as per Results presented at the 2023 American College of Clinical Pharmacology Annual Meeting
  • 12 Sep 2023 Primary endpoint has been met. (Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast), as per Results presented at the 2023 American College of Clinical Pharmacology Annual Meeting
  • 12 Sep 2023 Primary endpoint has been met. (Area under plasma concentration-time curve from zero to infinity (AUCinf), as per Results presented at the 2023 American College of Clinical Pharmacology Annual Meeting

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