The study of clinical bioequivalence drug Nativa (generic desmopressin acetate tablets) in patients with central diabetes insipidus
https://doi.org/10.14341/omet2016146-48
Abstract
Materials and methods. The study included 15 patients (9 women and 6 men) with central diabetes insipidus (CDI), compensated by therapy with a tablet formulation Minirin (diuresis up to 3000 ml). The average age of the patients was 44 ± 8 years. For 3 days during treatment Minirin we evaluated the clinical manifestations of the CDI. On the fourth day, Minirin was replaced by Nativa in the equivalent dose, with further correction whennecessary. From the 4th to the 6th day of treatment with Nativawe assessed the same parameters as on the initial therapy.
Results. The vast majority of patients did not require dose adjustment and, if necessary, dose adjustment was small and accounted for about 20% of the original dose. Average dose did not differ in patients receiving Minirin or Nativa, 0.43 ± 0.26 vs. 0.45 ± 0.32 (p> 0.05).
Conclusions. Nativa is characterized by therapeutic equivalence to Minirin in patients with a central form of diabetes insipidus.
About the Authors
Ekaterina A. Pigarova
Endocrinology Research Centre
Russian Federation
Russian Federation
Larisa K. Dzeranova
Endocrinology Research Centre
Russian Federation
Russian Federation
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Pigarova E.A., Dzeranova L.K. The study of clinical bioequivalence drug Nativa (generic desmopressin acetate tablets) in patients with central diabetes insipidus. Obesity and metabolism. 2016;13(1):46-48. (In Russ.) https://doi.org/10.14341/omet2016146-48
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