Comparing Sildenafil Products for Erectile Dysfunction
This study is comparing how different forms of sildenafil (a medication for erectile dysfunction), including Hezkue®, Hezkue Turbo®, and various commercial products like Viagra® and BlueChew, are absorbed by the body. Researchers want to see if there are differences in how quickly and how much of the drug gets into the bloodstream when taken with food, and if there are any differences in side effects. You may be eligible to participate if you are a healthy male between 18 and 70 years old. The study aims to enroll 72 participants.
- Study design
- This is an interventional study comparing different sildenafil products in 72 healthy male participants.
- What's involved
- You will take a single oral dose of a test product after a high-fat meal, have blood samples taken over 4 hours, and be monitored for side effects for up to 4 days after each dose. You may return for additional visits to test other products with a 4-day break in between.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be monitored for side effects and overall health for up to 4 days after each dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07117383
Hezkue®, Hezkue Turbo®, and Commercial Sildenafil Products in Fed Healthy Male Subject
Not Yet Recruiting
PHASE1Ages 18–70InterventionalTreatmentAspargo Labs, Inc
~72 participants
Updated 2025-12-12 on ClinicalTrials.gov
What's tested:ASP-001.1ASP-001Commercial Sildenafil and Sildenafil/Tadalafil Products
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tmax - Time to Maximum Observed Plasma Concentration of Sildenafil
Measured over Baseline and up to 4 hours post-dose at 23 specified timepoints
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Mario Guralnik, PhD · PRINCIPAL_INVESTIGATOR · Aspargo Labs, Inc
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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 to dosing.
Known hypersensitivity to sildenafil, tadalafil, vardenafil, or any component of the investigational product (e.g., peppermint oil).
History of significant food or drug allergies.
History of drug abuse within the past year or positive drug screen at screening.
Regular alcohol consumption exceeding 15 units per week.
Use of CYP450 enzyme inhibitors within 14 days prior to dosing.
Use of CYP450 enzyme inducers or St. John's Wort within 28 days prior to dosing.
Blood donation or significant blood loss within 3 months before screening.
Plasma donation within 14 days prior to first dose.
Inadequate venous access for repeated blood sampling.
Difficulty fasting or inability to consume standardized meals.
Intolerance to fatty foods or inability to consume a high-fat, high-calorie breakfast.
Difficulty swallowing.
Regular use of tobacco or nicotine products within 4 weeks prior to screening.
Major surgery within 3 months or minor surgery within 1 month before screening.
Considered unsuitable for study participation by the Investigator.
Institutionalized status.
Use of hormone replacement therapy within 6 months prior to dosing.
Consumption of Seville oranges, grapefruit, or pomelo within 7 days prior to dosing.
Consumption of caffeine, xanthine-containing products, or poppy seeds within 48 hours prior to dosing.
Receipt of a COVID-19 vaccine within 3 days prior to dosing.
Presence of braces, retainers, dentures, partial dentures, or tongue piercings.
Use of nitric oxide donors, organic nitrates/nitrites, antihypertensive medications, or PDE5 inhibitors within 14 days of dosing.
Blood pressure or heart rate outside acceptable ranges:
Systolic BP \<90 or \>140 mmHg
Diastolic BP \<50 or \>90 mmHg
Heart rate \<50 or \>100 bpm
What this trial measures
- Tmax - Time to Maximum Observed Plasma Concentration of SildenafilBaseline and up to 4 hours post-dose at 23 specified timepoints
Measurement of the time (Tmax) to reach maximum observed plasma concentration of sildenafil following a single oral dose under fed conditions.
- Cmax - Maximum Observed Plasma Concentration of SildenafilBaseline and at 23 timepoints within 4 hours post-dose.
Measurement of the maximum observed plasma concentration (Cmax) of sildenafil following a single oral dose of study drug.