This is a randomized, open-label, single-dose, five-period crossover, relative bioavailability study to evaluate tadalafil gummy 10mg and tadalafil oral tablets 10mg in healthy volunteers
male 19-65 years of age;
Available to participate for the planned duration of the study;
Able and willing to complete the informed consent process;
Agree to have blood samples collected and stored for the study;
A condition in which repeated blood draws poses more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access;
A condition that requires active medical intervention or monitoring to avert serious danger to the subject's health or well-being;
subjects with dentures, partial dentures or braces, subjects with swallowing disorders and subjects who abuse drugs, alcohol or tobacco;
Currently taking nitrates or nitro compounds, alpha blockers, antihypertensives, alcohol, CYP3A4 inhibitors, CYP3A4 inducers;
Crossover
Tadalafil 10 MG
Drugcomparison of tadalafil gummy 10mg and tadalafil oral tablet 10mg
maximum plasma cetirizine concentration (Cmax)
PK blood samples to measure plasma concentrations of tadalafil will be collected by direct venipuncture or by use of an indwelling cannula. Blood will be collected into tubes containing K2EDTA for determination of plasma tadalafil concentration at time 0 (within 60 minutes pre-dose), 10, 20 minute post-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post-dose. Plasma tadalafil concentrations will be listed at each time point by subject and summarized by treatment at each time point using descriptive statistics (n, mean, standard deviation (SD), Coefficient of variation (CV%), median, minimum and maximum values). Pharmacokinetic calculations will be performed based on actual time of blood sample collection, using non-compartmental methods with Phoenix WinNonlin Version 8.1 (Certara USA, Inc., Princeton, New Jersey, USA). Plots of mean concentrations of plasma tadalafil versus time will be generated and Cmax will be generated from the plot.
area under the plasma drug concentration versus time curve (AUC)
AUC will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ). AUC will be calculated to the last measurable observation (AUC0-t) and extrapolated to infinity (AUC0 ∞).
time to Cmax (Tmax)
Tmax will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).
elimination half-life (t½)
t½ will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).
terminal elimination rate constant (Kel).
Kel will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).
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