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

NCT07290400 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-12-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Aspargo Labs, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2026-06-15
Completion
2026-06-28
FDA Drug
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290400 on ClinicalTrials.gov