Bioequivalence Study of Vildagliptin and Metformin Fixed Dose Combinations in Healthy Volunteers
Abstract
Aim: To evaluate the comparative oral bioavailability of single dose of Vildamac-M® (fixed dose combination
of Vildagliptin and Metformin hydrochloride 50 mg/1000 mg, film-coated tablets Macleods Pharmaceuticals
Limited, India) to Eucreas® (Vildagliptin and Metformin hydrochloride 50 mg/1000 mg film-coated tablets
Novartis Pharmaceuticals Ltd., UK) in healthy, adult, human volunteers under fed condition. Additionally,
safety and tolerability of test and reference product was also evaluated.
Methods: This was an open label, balanced, analyst blind, randomized, two- treatment, two-period, two sequence
and crossover bioequivalence study with 07 days wash out period in 12 healthy, adult, human
volunteers. The study compared oral bioavailability of two formulations Vildamac-M® versus Eucreas® as
one tablet in single dose administered in fed condition.
Results: The 90% confidence intervals for the ratio (Test/Reference) of Cmax and AUC0-48 for Vildamac-M®
were within the acceptable limits of bioequivalence 80.00% – 125.00%. Ratio (T/R) for Cmax and AUC0-48 found
to be 101.99% and 105.61% for metformin respectively and 97.27% and 101.05% for vildagliptin respectively.
The highest intra subject C.V. was observed to be 8.95% for metformin and 15.85% for vildagliptin.
There was no adverse event occurred during the study and both test and reference products were safe and
well tolerated in fed condition.
Conclusion: Vildamac-M® the test formulation was found to bioequivalent with the reference product
Eucreas®.
Conflict of Interest: All authors have authored this manuscript in the capacity of paid employees of Macleaods
Pharmaceuticals Limited. Mumbai, India.
Funding Source: Macleods Pharmaceuticals Limited, Mumbai, India.
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