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Bioequivalence of a Low Strength Fixed Dose Combination Tablet of Empagliflozin/Linagliptin/Metformin Extended Release Compared to the Free Combination of Empagliflozin, Linagliptin, and Metformin Extended Release Tablets Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)

Trial Profile

Bioequivalence of a Low Strength Fixed Dose Combination Tablet of Empagliflozin/Linagliptin/Metformin Extended Release Compared to the Free Combination of Empagliflozin, Linagliptin, and Metformin Extended Release Tablets Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Jun 2019

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At a glance

  • Drugs Empagliflozin/linagliptin/metformin (Primary) ; Empagliflozin; Linagliptin; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Pharmacokinetics
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 04 Jun 2019 According to an Eli Lilly Media release, Boehringer Ingelheim and Lilly plans to present results from this trial at a medical congress later this year.
    • 04 Jun 2019 According to an Eli Lilly Media release, Boehringer Ingelheim and Eli Lilly announced that the U.S. Food and Drug Administration(FDA) has accepted the New Drug Application(NDA) for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended release(XR) for the treatment of adults with type 2 diabetes based on two trials NCT03259490 and NCT03629054.
    • 06 Nov 2018 Status changed from active, no longer recruiting to completed.
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