Value through Innovation27 July 2016

Clinical Study Results

  • SYNJARDY ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1276.1
    Study Indication Diabetes Mellitus, Type 2
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase III
    Study Title

    A 24-week phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of twice daily oral administration of empagliflozin + metformin compared with the individual components of empagliflozin or metformin in drug naive patients with type 2 diabetes mellitus

    Study Document Trial synopsis 1276.1_DR english
  • SYNJARDY ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1276.10
    Study Indication Diabetes Mellitus, Type 2
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double blind, placebo controlled, parallel group efficacy and safety study of oral administration of empagliflozin twice daily versus once daily in two different daily doses over 16 weeks as add-on therapy to a twice daily dosing regimen of metformin in patients with type 2 diabetes mellitus and insufficient glycaemic control

    Study Document Trial synopsis 1276.10_DR english
  • SYNJARDY ® - Healthy
    Clinical Study Number 1276.23
    Study Indication Healthy
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of empagliflozin (12.5 or 5 mg)/metformin (850 mg or 500 mg) fixed dose combination tablets compared to single tablets administered together to healthy Chinese male and female volunteers in an open-label, randomised, single-dose, two-way crossover study

    Study Document Trial synopsis 1276.23 english
  • SYNJARDY ® - Healthy
    Clinical Study Number 1276.24
    Study Indication Healthy
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of empagliflozin/metformin (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions (an open label, randomised, single dose, two period, two sequence crossover study)

    Study Document Trial synopsis 1276.24 english
  • SYNJARDY ® - Healthy
    Clinical Study Number 1276.5
    Study Indication Healthy
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a 12.5 mg BI 10773 / 1000 mg metformin fixed dose combination tablet compared with its monocomponents and administered with and without food (an open-label, randomised, single-dose, three-way crossover, Phase I trial in healthy volunteers)

    Study Document Trial synopsis 1276.5 english
  • SYNJARDY ® - Healthy
    Clinical Study Number 1276.6
    Study Indication Healthy
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of empagliflozin/metformin (500 mg) fixed dose combination tablets compared to single tablets administered together in healthy male and female volunteers under fed conditions (an open-label, randomised, single-dose, four-way crossover study)

    Study Document Trial synopsis 1276.6_DR english
  • SYNJARDY ® - Healthy
    Clinical Study Number 1276.7
    Study Indication Healthy
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of empagliflozin/metformin (850 mg) fixed dose combination tablets compared to single tablets administered together in healthy male and female volunteers under fed conditions (an open-label, randomised, single-dose, four-way crossover study)

    Study Document Trial synopsis 1276.7 english
  • SYNJARDY ® - Healthy
    Clinical Study Number 1276.8
    Study Indication Healthy
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of empagliflozin/metformin fixed dose combination tablets compared to single tablets administered together in healthy male and female volunteers under fed and fasted conditions (an open-label, randomised, single-dose, crossover study)

    Study Document Trial synopsis 1276.8 english
  • SYNJARDY ® - Healthy
    Clinical Study Number 1276.9
    Study Indication Healthy
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 5 mg BI 10773 administered twice daily compared to 10 mg BI 10773 given once daily after multiple oral doses in healthy male and female volunteers (an open-label, randomised, crossover, clinical phase I study)

    Study Document Trial synopsis 1276.9 english
  • SYNJARDY ® - Healthy
    Clinical Study Number 1276.27
    Study Indication Healthy
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, randomised, single-dose, two-way crossover study in healthymale and female subjects to evaluate the bioequivalence of two fixed dose combination tablets of empagliflozin 12.5 mg and metformin 500 mg compared with the free combination of empagliflozin 25 mg and metformin 1000 mg tablets under fed conditions

    Study Document Trial synopsis 1276.27_DR english
  • SYNJARDY ® - Healthy
    Clinical Study Number 1276.13
    Study Indication Healthy
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of two newly developed FDC tablet strengths (25mg/1000mg and 12.5mg/750mg) of Empagliflozin/Metformin extended release compared with the free combination of Empagliflozin and Metformin extended release in healthy subjects (an open-label, randomised, single dose, two-way crossover study)

    Study Document Trial synopsis 1276.13 english
  • SYNJARDY ® - Healthy
    Clinical Study Number 1276.14
    Study Indication Healthy
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of two newly developed FDC tablet strengths (10 mg/1000 mg and 5mg/750mg) of empagliflozin/metformin extended release compared with the free combination of empagliflozin and metformin extended release in healthy subjects (an open-label, randomised, single dose, two-way crossover study)

    Study Document Trial synopsis 1276.14 english
  • SYNJARDY ® - Healthy
    Clinical Study Number 1276.15
    Study Indication Healthy
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a fixed dose combination tablet of empagliflozin/metformin extended release (25 mg/1000 mg) compared with the free combination of empagliflozin and metformin extended release tablets in healthy subjects following a high-fat, high-caloric meal (an open-label, randomised, single dose, crossover trial)

    Study Document Trial synopsis 1276.15 english
  • SYNJARDY ® - Healthy
    Clinical Study Number 1276.28
    Study Indication Healthy
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a fixed dose combination tablet of empagliflozin/metformin extended release (10 mg/1000 mg) compared with the free combination of empagliflozin and metformin extended release tablets in healthy subjects following a high-fat, high-caloric meal (an open-label, randomised, single dose, crossover trial)

    Study Document Trial synopsis 1276.28 english

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