Generex reports positive results from metformin chewing gum trial

Results of this fully compliant ICH-GCP conducted study indicate that the MetControl metformin chewing gum and traditional metformin tablets are bioequivalent in respect of both the rate and the extent of systemic absorption such that MetControl and metformin tablets are therapeutically equivalent and therefore interchangeable.

The protocol for the study is an open-label, two-treatment, two-period, randomized, crossover study comparing MetControl and immediate release metformin tablets in healthy volunteers. The primary objective of the study is to determine if MetControl is bioequivalent to traditional immediate release metformin tablets.

Approximately 24 healthy subjects were selected for enrollment in the study, to evaluate the bioequivalence of 2 x 250mg MetControl in comparison to 500mg metformin tablets. The subjects received one assigned treatment during the first period and received the alternate treatment during the subsequent period. A seven day washout was included between the dose administrations.

Blood samples were collected and metformin was analyzed in plasma. Statistical analysis was performed to compare the bioequivalence of MetControl to the metformin tablets. Bioequivalence was established with a power of one based on 90% confidence interval (CI).

Preliminary data obtained from the study reveals that at a 90% CI, the area under the drug plasma concentration over time curve and the average maximum metformin plasma concentration were within the bioequivalence accepted range of 80% – 125%. The same profiles were also observed in log-transformed data, the company said.

Anna Gluskin, president and CEO of Generex, said: These results are very encouraging. We look forward to proceeding with the regulatory path to product commercialization. MetControl will be a complementary product to Generex Oral-lyn, our proprietary oral insulin spray product.