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

Part of paid clinical trials in New York, New York.

Sponsor
Aspargo Labs, Inc
Study ID
NCT07117383
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Erectile Dysfunction

Eligibility Criteria

Sex
MALE
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • ASP-001.1 — DEVICE
    Bottle/pump containing ASP-001.1 suspension
  • ASP-001 — DRUG
    Oral liquid suspension of sildenafil
  • Commercial Sildenafil and Sildenafil/Tadalafil Products — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 31, 2026
Status verified
Aug 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Hezkue Formulations
    Participants in this arm receive a single dose of 100mg (miligrams) of either Hezkue® (ASP-001) or Hezkue Turbo® (ASP-001.1), both liquid formulations containing sildenafil citrate.
  • Experimental: Commercially Available Sildenafil Products
    Participants in this arm receive a single dose of one of several comparator products, including commercially available sildenafil tablets or sildenafil + tadalafil combination chewables.

Primary Outcome Measure

Tmax - Time to Maximum Observed Plasma Concentration of Sildenafil [ Time Frame: Baseline and up to 4 hours post-dose at 23 specified timepoints ]

Locations (1)

FacilityCityStateZIPSite coordinators
Aspargo LabsNew YorkNew York10004
Mario Guralnik, PhD
[email protected]
714-818-3000

Find similar trials in New York, NY

By research site
Aspargo Labs· New York, NY

Related Studies