Bioequivalence was demonstrated separately between the administration of the dutasteride-tamsulosin combination and the simultaneous dosing of dutasteride and tamsulosin in capsules.
Bioequivalence studies of single doses were carried out both in the fasting state and after meals. Compared with the fasting state, a 30% decrease in the Cmax of the ingredient tamsulosin of the dutasterid-tamsulosin combination was noted after a meal. Food did not affect Tamsulosin AUC.
Dutahair. Dutasteride has a large volume of distribution (300–500 l) and high binding to plasma proteins (> 99.5%). After daily dosing, the concentration of dutasteride in plasma is 65% of the equilibrium concentration after 1 month and about 90% after 3 months.
Equilibrium plasma concentration of about 40 ng / ml is achieved after 6 months of administration at a dose of 0.5 mg / day. The average value of dutasteride intake from plasma to seminal fluid is 11.5%.
Tamsulosin. In men, tamsulosin is approximately 99% bound to plasma proteins. The volume of distribution is small (about 0.21 / kg body weight).
Indications for use
Treatment and prevention of progression of good-quality prostatic hyperplasia, reducing its size, reducing symptoms of the disease, improving urination, reducing the risk of acute urinary retention and the need for surgical treatment.