The objective of this phase 1, open-label, single-center, two-way crossover trial is to evaluate the pharmacokinetics (PK), safety, and tolerability of 100 mg ASP-001 oral liquid suspension versus 100 mg Viagra (sildenafil citrate) tablets in fasted, healthy male volunteers
This is a Phase 1, open-label, single-center, two-way crossover study to evaluate the pharmacokinetics (PK), bioequivalence (BE), safety, and tolerability of ASP-001 (oral liquid suspension of sildenafil) compared to Viagra (sildenafil film-coated tablet) under fasted conditions in 56 healthy adult male participants. The study aims to demonstrate bioequivalence between the ASP-001 and Viagra formulations and to evaluate whether the absorption rate of ASP-001 is superior to that of Viagra. Additionally, the study assesses the tolerability of ASP-001, including potential for oral irritation, dizziness, or headache. Participants are randomized to one of these two sequences: * Sequence 1: ASP-001 in Period I, Viagra in Period II. * Sequence 2: Viagra in Period I, ASP-001 in Period II There is a washout period of 6 days between treatment periods. Enrollment may be increased at any point in this trial to ensure a minimum of 56 evaluable participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Evolution Research Group, Clinical Pharmacology of Miami (CPMI)
Miami, Florida, United States
Evolution Research Group, Clinical Pharmacology of Miami (CPMI)
Miami, Florida, United States
Cmax
The PK profile of ASP-001 and Viagra in healthy male subjects. Calculation of maximum plasma concentration (Cmax) over the specified timeframe.
Time frame: Baseline and at 24 different timepoints during the 24 hour post-dose
Absorption
To determine if the rate and extent of absorption are similar for 100 mg of ASP-001 administered as 8 pumps of the 25 mg/mL oral liquid suspension of sildenafil compared to 100 mg Viagra (sildenafil) administered in the form of a film-coated tablet.
Time frame: Baseline and at several timepoints during the 24 hour post-dose
AUCt
The PK profile of ASP-001 and Viagra in healthy male subjects. Calculation of the area under the plasma concentration versus time curve will be calculated using the linear trapezoidal rule from the zero time point to the last quantifiable concentration (AUCt).
Time frame: Baseline and at 24 different timepoints during the 24 hour post-dose
AUCi
The PK of ASP-001 and Viagra in healthy male subjects. The area under the plasma concentration versus time curve from zero to infinity (AUCi) will be calculated by adding the last quantifiable concentration (Ct)/ elimination rate contant (Kel) to AUCt.
Time frame: Baseline and at 24 different timepoints during the 24 hour post-dose
Tmax
The PK of ASP-001 and Viagra in healthy male subjects. Calculation of the time of the maximum measured plasma concentration (Tmax). If the maximum plasma concentration occurs at more than one time point, the first is chosen as Tmax.
Time frame: Baseline and at 24 different timepoints during the 24 hour post-dose
Kel
The PK of ASP-001 and Viagra in healthy male subjects. Calculation of the terminal elimination rate constant obtained from the slope of the line, fitted by linear least squares regression, through the terminal points of the log (base e) of the concentration versus time plot for these timepoints.
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Time frame: Baseline and at 24 different timepoints during the 24 hour post-dose
tHalf
PK of ASP-001 and Viagra in healthy male subjects. The half-life will be calculated by the equation tHalf = 0.693/ Kel. Apparent elimination half-life.
Time frame: Baseline and at 24 different timepoints during the 24 hour post-dose
Number of participants with oral irritation, dizziness, or headache.
To determine the potential of ASP-001 to cause oral irritation, dizziness, or headache. Descriptive summaries (mean, standard deviation (SD), median, minimum, and maximum) of actual values and changes from baseline will be provided.
Time frame: Baseline and different timepoints during the 24 hour post-dose
Number of participants with adverse events
The frequency and type of adverse events reported during the study.
Time frame: Baseline and at several timepoints during the 24 hours post-dose