A Phase 1 Pharmacokinetic Study Comparing Hezkue® (ASP-001), Hezkue Turbo® (ASP-001.1), and Select Commercially Available Sildenafil Products Under Fed Conditions in Healthy Adult Male Subjects
Aspargo Labs, Inc
Summary
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.
Description
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 sildenaf…
Eligibility
- Age range
- 18–70 years
- Sex
- Male
- Healthy volunteers
- Yes
Inclusion Criteria: * Participant must be informed of the nature of the study and voluntarily agree to participate by signing an informed consent form prior to any study-specific procedures. * Participant must be a healthy male, aged 18 to 70 years (inclusive) at the time of dosing. * Participant must be judged by the Investigator or designee to be in good general health, as documented by medical history, physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG). Any deviations from normal ranges must be assessed and deemed not clinically significant by…
Interventions
- DeviceASP-001.1
Bottle/pump containing ASP-001.1 suspension
- DrugASP-001
Oral liquid suspension of sildenafil
- DrugCommercial Sildenafil and Sildenafil/Tadalafil Products
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.
Location
- Aspargo LabsNew York, New York