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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)

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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: 22 Feb 2020

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At a glance

Most Recent Events

  • 27 Jan 2020 According to an Eli Lilly Media release, U.S. Food and Drug Administration (FDA) has approved Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets) to lower blood sugar in adults with type 2 diabetes, along with diet and exercisebased on two trials NCT03259490 and NCT03629054.
  • 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.

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