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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
ASP-001.1
DeviceBottle/pump containing ASP-001.1 suspension
ASP-001
DrugOral liquid suspension of sildenafil
Commercial Sildenafil and Sildenafil/Tadalafil Products
DrugA 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Hezkue FormulationsExperimental treatment 2 interventions
Group B: Commercially Available Sildenafil ProductsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tmax - Time to Maximum Observed Plasma Concentration of Sildenafil
Measurement of the time (Tmax) to reach maximum observed plasma concentration of sildenafil following a single oral dose under fed conditions.
Time frame
Baseline and up to 4 hours post-dose at 23 specified timepoints2
Cmax - Maximum Observed Plasma Concentration of Sildenafil
Measurement of the maximum observed plasma concentration (Cmax) of sildenafil following a single oral dose of study drug.
Time frame
Baseline and at 23 timepoints within 4 hours post-dose.Secondary outcomes
1
Number of Participants Reporting Oral Irritation, Dizziness, or Headache
To assess the frequency and severity of oral irritation, dizziness, or headache following administration of ASP-001.1 (Hezkue Turbo). Descriptive summaries (mean, standard deviation, median, minimum, and maximum) of actual values and changes from baseline will be provided.
Time frame
From pre-dose through 96 hours post-dose.2
Number of Participants With Adverse Events
The frequency and type of adverse events reported during the study will be summarized, including severity and relationship to study drug.
Time frame
From pre-dose through 96 hours post-dose.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: