Study of the Pharmacokinetics of Extended Release Sildenafil
Purpose of the Study
The study aimed to compare how the drug Vildegra, approved in Russia, behaves in the body compared to the original drug, Viagra.
Materials and Methods
The study was designed as a prospective, open-label trial involving healthy male volunteers. A total of 48 men, aged 18 to 45, participated by taking one tablet of Vildegra on an empty stomach. Blood samples were collected before and at various intervals after taking the drug to measure the concentration of active substances. The study monitored participants’ health, including vital signs and any side effects.
Results
The findings showed that the pharmacokinetic parameters (AUC0-t, AUC0-, and Cmax) for Vildegra were similar to those of Viagra. However, the time to reach maximum concentration (tmax) and the half-life (t1/2) were slightly longer for Vildegra, likely due to its extended-release formulation. Out of 48 volunteers, 21% experienced mild side effects, but all recovered completely, and no serious side effects were reported.
Conclusion
The study concluded that Vildegra has comparable pharmacokinetics, good tolerability, and a satisfactory safety profile when compared to Viagra.
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