A Randomized, Open-label, Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Single Oral Dose Administration of a Fixed-Dose Combination of SYR-322 and Metformin Hydrochloride in Healthy Adult Male Subjects

Trial Profile

A Randomized, Open-label, Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Single Oral Dose Administration of a Fixed-Dose Combination of SYR-322 and Metformin Hydrochloride in Healthy Adult Male Subjects

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Feb 2017

At a glance

  • Drugs Alogliptin/metformin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Pharmacokinetics; Registrational
  • Sponsors Takeda
  • Most Recent Events

    • 28 Sep 2016 According to a company media release, Takeda has obtained the New Drug Application Approval from the Ministry of Health, Labour and Welfare for the Inisync Combination Tablets, a fixed-dose combination of Nesina and metformin hydrochloride for the treatment of type 2 diabetes, based on the results of this and other trials (see profile 250740).
    • 29 Oct 2014 New trial record
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