Aim: In order to evaluate the bioequivalence and benefits of a new dosage form of the type 5 phosphodiesterase inhibitor, sildenafil, two open-label studies in healthy male volunteers were carried out.
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Materials and methods: An open, randomized, crossover study to compare the pharmacokinetics after a single dose of sildenafil at a dosage of 50 mg on an empty stomach in a new spray form test drug and in a traditional tablet form comparison drug on 44 volunteers 18 to 43 years old was done. To assess the effect of food intake on pharmacokinetics, an open, non-randomized study was conducted on 6 healthy male volunteers from 23 to 35 years old who received sildenafil 50 mg after a meal in timely fashion: 1 spray, under the tongue, without drinking, 2 spray , in the mouth, drinking water and 3 the tablet form, drinking water.
For pharmacokinetic analysis, blood was analyzed for 24 hours. The main parameters were the rate maximum concentration; Cmax and the degree of absorption area under the pharmacokinetic curve "concentration-time" during the observation period; AUC0-t after a single dose of drugs.
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In addition, the pharmacokinetic profiles of the bioavailability of sildenafil and its active metabolite, N-desmethyl sildenafil, as well as the safety of the different dosage forms, were evaluated. In addition, it was shown that when taking Viagra after a meal, the determination of sildenafil in plasma was delayed after 30 minutes compared to the tested drugs after 10 minutes , however, significant differences in Tmax between the dosage forms were not seen.
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In two studies, most adverse events were mild to moderate and resolved uneventfully. Discussion: The bioavailability of the new dosage form, the sildenafil spray, is equivalent to the traditional form, however, it has an advantage in terms of onset of action.
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For example, when taking a spray, an earlier achievement of the maximum concentration of sildenafil and an earlier detection of sildenafil in plasma are shown compared to the traditional tablet form.
Conclusions: Our results suggest that the new dosage form of sildenafil is a reliable alternative therapeutic option for the treatment of erectile dysfunction.
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Keywords: N-desmethyl sildenafil; bioequivalence; pharmacokinetics; phosphodiesterase PDE5 inhibitor; sildenafil; spray. Abstract Aim: In order to evaluate the bioequivalence and benefits of a new dosage form of the type 5 phosphodiesterase inhibitor, sildenafil, two open-label studies in healthy male volunteers were carried out. Publication types Randomized Controlled Trial.
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Substances Vasodilator Agents Sildenafil Citrate.
