Introduction. Combination drug therapy is widely used to treat benign prostatic hyperplasia and associated symptoms of lower urinary tract dysfunction (LUTS/BPH). The most commonly used combination is alpha-1-adrenergic blockers (α1-AB) and testosterone-5-alpha reductase inhibitors (5αRI): finasteride or dutasteride. This publication is devoted to the new domestic combination drug «Predstanormix Duo» (JSC «Pharmasyntez», Russia) for the treatment of LUTS/BPH, containing fixed doses of dutasteride (0.5 mg) and tamsulosin (0.4 mg) in modifiedrelease capsules.

Materials and methods. The results of 3 groups of comparative clinical studies on the pharmacokinetics and bioequivalence of the drugs are presented: 1 – Predstanormix Tamlazin (tamsulosin) and Omnic; 2 – Predstanormix (dutasteride) and Avodart; 3 – Predstanormix Duo and Duodart.

Results. The studies demonstrated the bioequivalence of the compared drugs and the high safety of Predstanormix Duo. The values of the calculated 90% CI for the ratios of pharmacokinetic parameters after taking the test and reference drugs for the parameters AUC0-t and Cmax were, respectively: for dutasteride 96.31% (90.01-103.06) and 91.64 (86.05 – 97.6%); for tamsulosin 93.58% (88.01-99.49%) and 99.98% (92.68 – 107.84%). The curves profiles of the changes dynamics in the concentrations of dutasteride and tamsulosin in the blood serum of volunteers over time in linear and semilogarithmic coordinates after a single dose of the test drug and the comparison drug are identical.

Conclusion. The emergence of the first domestic combination drug Prestanormix Duo, containing fixed combination of dutasteride and tamsulosin, bioequivalent to the original drug, will not only increase the availability of a modern type of treatment for BPH patients at high risk of disease progression, but improves adherence to the therapy and will also achieve an economic effect with its long-term use.