NCT06782659

Study to Compare the Effects of Viagra® Vs Hezkue® in Healthy Fasted Male Participants.

A Phase 1 Pharmacokinetic/Bioequivalence Study of 100 Mg of HEZKUE® (ASP-001, Sildenafil) Versus 100 Mg of VIAGRA® (Sildenafil) Film-Coated Tablets Under Fasted Conditions in Healthy Adult Male Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Aspargo Labs, Inc · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this phase 1, open-label, single-center, two-way crossover trial is to evaluate the pharmacokinetics (PK), safety, and tolerability of 100 mg ASP-001 oral liquid suspension versus 100 mg Viagra (sildenafil citrate) tablets in fasted, healthy male volunteers

Detailed description

This is a Phase 1, open-label, single-center, two-way crossover study to evaluate the pharmacokinetics (PK), bioequivalence (BE), safety, and tolerability of ASP-001 (oral liquid suspension of sildenafil) compared to Viagra (sildenafil film-coated tablet) under fasted conditions in 56 healthy adult male participants. The study aims to demonstrate bioequivalence between the ASP-001 and Viagra formulations and to evaluate whether the absorption rate of ASP-001 is superior to that of Viagra. Additionally, the study assesses the tolerability of ASP-001, including potential for oral irritation, dizziness, or headache. Participants are randomized to one of these two sequences: * Sequence 1: ASP-001 in Period I, Viagra in Period II. * Sequence 2: Viagra in Period I, ASP-001 in Period II There is a washout period of 6 days between treatment periods. Enrollment may be increased at any point in this trial to ensure a minimum of 56 evaluable participants.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	ASP-001	Oral liquid suspension of sildenafil
DRUG	Viagra	Sildenafil film-coated tablet
DEVICE	ASP-001	Bottle/pump containing ASP-001 suspension

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2025-01-20
• Last updated: 2025-01-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study