| 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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