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

Starting soon · Phase 1

Conditions studied: Erectile Dysfunction

In brief

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 facts

Study ID

NCT07117383

Run by

Aspargo Labs, Inc

People needed

72

Starts

2026-01-01

Expected to finish

2026-03-01

Last updated by the study team

2025-12-12

Who can join

Age: 18 and older, up to 70. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Aspargo Labs — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.