The goal of this clinical trial is to compare how different sildenafil formulations are absorbed and tolerated in healthy adult males under fed conditions. The main questions it aims to answer are: Do Hezkue and Hezkue Turbo differ in absorption compared to other commercial sildenafil products? Are there any differences in safety or tolerability between the products? Researchers will compare multiple formulations to evaluate differences in drug absorption and side effects.
The goal of this clinical trial is to learn how different formulations of sildenafil-used to treat erectile dysfunction-are absorbed in the body when taken with food, and to understand how safe and well-tolerated they are in healthy adult males. The main questions it aims to answer are: How do the blood levels of sildenafil compare between Hezkue, Hezkue Turbo, and other commercial sildenafil products? Do differences in formulation (such as particle size or combination with tadalafil) affect the absorption or safety profile? Researchers will compare Hezkue and Hezkue Turbo to other sildenafil-containing products (such as Pfizer Viagra, BlueChew, and Ro Sparks) to see if there are differences in how quickly and how much of the drug enters the bloodstream. Participants will: * Take a single oral dose of one of the test products after eating a high-fat meal. * Have blood samples taken over a 4-hour period to measure drug levels. * Be monitored for side effects and overall health for up to 4 days after each dose. * Have the option to return for additional visits to test other products, with a 4-day break in between.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Bottle/pump containing ASP-001.1 suspension
Oral liquid suspension of sildenafil
A selection of marketed sildenafil or sildenafil + tadalafil products used as comparators. Includes tablets and chewables such as Viagra®, Galotam, BlueChew, Aristo Sildaristo, Lemonaid Viagra, Ro Sparks, Hims Hard Mints, and Hello Cake ED Cake Meds.
Aspargo Labs
New York, New York, United States
Tmax - Time to Maximum Observed Plasma Concentration of Sildenafil
Measurement of the time (Tmax) to reach maximum observed plasma concentration of sildenafil following a single oral dose under fed conditions.
Time frame: Baseline and up to 4 hours post-dose at 23 specified timepoints
Cmax - Maximum Observed Plasma Concentration of Sildenafil
Measurement of the maximum observed plasma concentration (Cmax) of sildenafil following a single oral dose of study drug.
Time frame: Baseline and at 23 timepoints within 4 hours post-dose.
Number of Participants Reporting Oral Irritation, Dizziness, or Headache
To assess the frequency and severity of oral irritation, dizziness, or headache following administration of ASP-001.1 (Hezkue Turbo). Descriptive summaries (mean, standard deviation, median, minimum, and maximum) of actual values and changes from baseline will be provided.
Time frame: From pre-dose through 96 hours post-dose.
Number of Participants With Adverse Events
The frequency and type of adverse events reported during the study will be summarized, including severity and relationship to study drug.
Time frame: From pre-dose through 96 hours post-dose.
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