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A multi-centric, randomized, double blind, parallel group, active controlled, comparative Phase III clinical trial to evaluate the efficacy and safety of FDC of Bepotastine besilate 10mg/10mg + Montelukast sodium 5mg/10mg tablet versus Montelukast Sodium 5mg and Montelukast Sodium 10mg tablet in subjects diagnosed with Allergic Rhinitis.

Trial Profile

A multi-centric, randomized, double blind, parallel group, active controlled, comparative Phase III clinical trial to evaluate the efficacy and safety of FDC of Bepotastine besilate 10mg/10mg + Montelukast sodium 5mg/10mg tablet versus Montelukast Sodium 5mg and Montelukast Sodium 10mg tablet in subjects diagnosed with Allergic Rhinitis.

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 31 Jan 2020

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At a glance

  • Drugs Bepotastine besilate/montelukast (Primary) ; Montelukast
  • Indications Allergic rhinitis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Windlas Biotech

Most Recent Events

  • 31 Jan 2020 New trial record

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