NCT07117383

Hezkue®, Hezkue Turbo®, and Commercial Sildenafil Products in Fed Healthy Male Subject

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Aspargo Labs, Inc · Industry
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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 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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	ASP-001.1	Bottle/pump containing ASP-001.1 suspension
DRUG	ASP-001	Oral liquid suspension of sildenafil
DRUG	Commercial 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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-08-12
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study