The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fed Versus 100 mg of Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fasted Conditions in Healthy Adult Male Subjects

Part of paid clinical trials in New York, New York.

Sponsor
Aspargo Labs, Inc
Study ID
NCT06872866
Phase
PHASE1
Status
Recruiting
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Conditions

  • Erectile Dysfunction

Eligibility Criteria

Sex
MALE
Age
20 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • ASP-001.1 — DRUG
    Oral liquid suspension of sildenafil
  • ASP-001.1 — DEVICE
    Bottle/pump containing ASP-001.1 suspension

Study Details

The objective of this phase 1 study is to evaluate the food effect of 100 mg Hezkue Turbo® (ASP-001.1, sildenafil) under fed versus 100 mg of Hezkue Turbo® (ASP-001.1, sildenafil) under fasted conditions in healthy adult male subjects

Key Dates

Start date
Apr 15, 2025
Status verified
Nov 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 - Fasted vs Fed Conditions
    Participants receive 100mg of ASP-001.1 first under fasted conditions and under fed conditions after
  • Experimental: Arm 2- Fed vs Fasted Conditions
    Participants receive 100mg of ASP-001.1 first under fed conditions and under fasted conditions after

Primary Outcome Measure

Cmax [ Time Frame: Baseline and at 26 different timepoints during the 24 hour post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Aspargo LabsNew YorkNew York10004
Mario Guralnik, PhD
[email protected]
714-818-3000

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Aspargo Labs· New York, NY

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