Not Yet RecruitingPhase 1

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

United States72 participantsStarted 2026-01

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 the Investigator or designee. * Participant must have a creatinine clearance (CrCl) value greater than 80 mL/min, as calculated by the Cockcroft-Gault equation. * Participant must agree to practice an acceptable method of contraception throughout the clinical trial, as outlined in the protocol. Exclusion Criteria: * Unwilling or unable to comply with study procedures. * Use of any investigational drug (except Hezkue/Hezkue Turbo) within 30 days prior to dosing. * History of significant renal, hepatic, cardiovascular (including orthostatic hypotension), psychiatric, neoplastic, infectious disease, or diabetes mellitus. * Clinically significant abnormal lab results, vital signs, or ECGs. * Any hepatic impairment or abnormal liver function tests. * Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody. * Clinically significant illness within 28 days prior t…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tmax - Time to Maximum Observed Plasma Concentration of Sildenafil

Timeframe: Baseline and up to 4 hours post-dose at 23 specified timepoints

Cmax - Maximum Observed Plasma Concentration of Sildenafil

Timeframe: Baseline and at 23 timepoints within 4 hours post-dose.

Trial details

NCT IDNCT07117383

SponsorAspargo Labs, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

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