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PK and Onset of Hezkue Oral Sildenafil Suspension After Alcohol Consumption

ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-70
SponsorAspargo Labs, Inc

About this trial

This is an open-label, randomized study evaluating the pharmacokinetics and onset performance of Hezkue® oral sildenafil suspension administered following moderate alcohol consumption in healthy adult subjects. Participants will receive Hezkue® under controlled alcohol-exposure conditions. Pharmacokinetic sampling, onset assessments, and safety evaluations will be conducted throughout the study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female adults 21 to 55 years of age, inclusive.

Disqualifiers

History or presence of any clinically significant cardiovascular disease, including but not limited to coronary artery disease, heart failure, clinically important arrhythmias, or uncontrolled hypertension or hypotension.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Hezkue Oral Sildenafil Suspension

    Drug

    Hezkue® oral sildenafil suspension will be administered as a single oral dose following controlled moderate alcohol consumption under fasting or standardized conditions, according to the study schedule, to evaluate pharmacokinetics, onset performance, and safety.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Single-Arm CrossoverExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Sildenafil

Time frame
From predose up to approximately 24 hours postdose in each study period
2

Maximum Observed Plasma Concentration (Cmax) of Sildenafil

Time frame
From predose up to approximately 24 hours postdose in each study period
3

Time to Onset of Effect as Assessed by Participant-Reported Onset

Time frame
From dosing up to approximately 4 hours postdose in each study period

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aspargo Labs, Inc

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: