A phase III multicenter study to evaluate the safety/efficacy of APC-111 MP [amoxicillin multi particulate] tablet qd vs. penicillin VK [phenoxymethylpenicillin potassium] qid both for 10 days treatment of pharyngitis secondary to S. pyogenes in adolescents/adults

Trial Profile

A phase III multicenter study to evaluate the safety/efficacy of APC-111 MP [amoxicillin multi particulate] tablet qd vs. penicillin VK [phenoxymethylpenicillin potassium] qid both for 10 days treatment of pharyngitis secondary to S. pyogenes in adolescents/adults

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jan 2008

At a glance

  • Drugs Amoxicillin; Phenoxymethylpenicillin potassium
  • Indications Pharyngitis; Streptococcal infections; Tonsillitis
  • Focus Registrational; Therapeutic Use
  • Sponsors MiddleBrook Pharmaceuticals
  • Most Recent Events

    • 24 Jan 2008 Based on the results from this study, an NDA for the once-daily 775mg extended-release formulation (Moxatag) for adolescents and adults has been approved by the US FDA.
    • 26 Nov 2005 New trial record.
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