Diabetes & Cholesterol Management

Study Design Randomized, double blind study with 3000 patients
Indication Diabetes & Cholesterol Management
Participating countries South Africa, Malaysia, Thailand
Project Scope
  • Handling of Local FDA, import, CDSCO & export.
  • Import of innovator tablets & DB capsules.
  • Stability study.
  • Blinding of IMP with over encapsulation.
  • Primary packing in bottles, labeling of bottles with randomized double panel label. Assembling of bottles in labelled patient kits as per dose regimen(Run in and treatment).
  • Shipping to sites in India and depots of South Africa, Malaysia & Thailand at 15 Deg C -25 Deg C.

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