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

NCT07117383 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-12-12

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Aspargo Labs, Inc

    lead INDUSTRY

Principal Investigators

  • Mario Guralnik, PhD · Aspargo Labs, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07117383 on ClinicalTrials.gov