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
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
Treatments tested in this trial
- Hezkue Oral Sildenafil Suspension
Treatment groups
24 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov