Hezkue®, Hezkue Turbo®, and Commercial Sildenafil Products in Fed Healthy Male Subject
ConditionErectile Dysfunction
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-70
SponsorAspargo Labs, Inc
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ASP-001.1
- ASP-001
- Commercial Sildenafil and Sildenafil/Tadalafil Products
Treatment groups
72 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov