Food effect on pharmacokinetic profiles of sildenafil 100 mg oral films in healthy male volunteers: results from two randomized, single dose, crossover studies
Abstract
Background: Decades after it was first put on the market, sildenafil is still a very successful treatment for erectile dysfunction. New formulations, such orodispersible films (ODFs), offer more convenience allowing more discreet use and enabling people who might have trouble swallowing tablets to take the drug.
Aim: To evaluate the impact of food and water on sildenafil ODF as compared to sildenafil film-coated tablet (FCT) and to assess the safety and palatability of the orodispersible formulation.
Methods: Two randomized, single-dose, three-period, crossover studies were conducted on healthy male volunteers. The first study, involving 45 subjects, was designed to compare ODF versus FCT under fasting conditions and to study the effect of high-fat, high-calorie meal on ODF pharmacokinetic (PK) profiles. The second study, involving 35 subjects, compared ODF versus FCT under fed conditions and the effect of water on ODF PK profiles. Blood samples were collected within 24 h post-dosing to measure plasma sildenafil and its metabolite, N-desmethyl-sildenafil.
Outcomes: Primary outcomes were maximum observed plasma concentration (C max), the area under the concentration-time curve (AUC), and the time of maximum observed plasma concentration (T max). Secondary outcomes included palatability and safety.
Results: Food delayed sildenafil 100 mg ODF T max by 1.45 h and decreased C max by 45% but did not affect the extent of systemic exposure to sildenafil (AUC). Bioequivalence was…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 45 participants or records.
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