NCT07302698

PK and Onset of Hezkue Oral Sildenafil Suspension After Alcohol Consumption

Evaluation of the Pharmacokinetics and Onset Performance of Hezkue® Oral Sildenafil Suspension Following Alcohol Consumption in Healthy Adults

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Aspargo Labs, Inc · Industry
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Hezkue Oral Sildenafil Suspension	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.

Timeline

• Start date: 2026-03-15
• Primary completion: 2026-05-15
• Completion: 2026-05-28
• First posted: 2025-12-24
• Last updated: 2025-12-24

Regulatory

• FDA-regulated drug study