USA-based Generex Biotechnology, which focuses on drug delivery for metabolic diseases through the inner lining of the mouth, says it has finalized the protocol for Metcontrol, its proprietary metformin chewing gum product, and will be proceeding with applications to regulatory agencies for approval for a clinical study.
The protocol is an open-label crossover study comparing Generex' product and immediate-release tablets in healthy volunteers. The company anticipates that around 75-100 patients will participate in the study.
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