NCT07290400

Effect of Moderate Alcohol on Absorption and Onset of Hezkue Sildenafil Suspension

Phase 2 Crossover Study Assessing the Effect of Moderate Alcohol Intake on the Absorption and Onset of Action of Hezkue® Sildenafil Oral Suspension

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Aspargo Labs, Inc · Industry
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, open-label, randomized crossover study assessing the effect of moderate alcohol intake on the absorption and onset of action of Hezkue® sildenafil oral suspension in adult subjects. Participants will receive Hezkue® under different alcohol intake conditions in randomized sequence. Pharmacokinetic sampling and onset assessments will be performed after each administration, and safety will be monitored throughout the study.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Hezkue Sildenafil Oral Suspension	Hezkue® sildenafil oral suspension will be administered as a single oral dose in each study period under different alcohol intake conditions (such as with and without moderate alcohol consumption), according to the randomized crossover design. Pharmacokinetic, absorption, onset of action, and safety parameters will be assessed after each administration.
OTHER	Moderate Alcohol Intake	A standardized moderate amount of alcohol will be administered under controlled conditions prior to dosing with Hezkue® sildenafil oral suspension in designated study periods, according to the protocol-defined alcohol intake procedures.

Timeline

• Start date: 2026-04-15
• Primary completion: 2026-06-15
• Completion: 2026-06-28
• First posted: 2025-12-18
• Last updated: 2025-12-18

Regulatory

• FDA-regulated drug study