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

Part of paid clinical trials in Miami, Florida.

Sponsor
Aspargo Labs, Inc
Study ID
NCT06782659
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Erectile Dysfunction

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • ASP-001 — DRUG
    Oral liquid suspension of sildenafil
  • Viagra — DRUG
    Sildenafil film-coated tablet
  • ASP-001 — DEVICE
    Bottle/pump containing ASP-001 suspension

Study Details

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

Key Dates

Start date
Jan 31, 2025
Status verified
Jan 2025
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025

Study Design

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

Arms

  • Experimental: Arm 1 - ASP-001 and Viagra
    Participants receive 100 mg of ASP-001 followed by a 6 day washout before receiving 100 mg of Viagra
  • Experimental: Arm 2 - Viagra and ASP-001
    Participants receive 100 mg of Viagra followed by a 6 day washout before receiving 100 mg of ASP-001

Primary Outcome Measure

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

Locations (2)

FacilityCityStateZIPSite coordinators
Evolution Research Group, Clinical Pharmacology of Miami (CPMI)MiamiFlorida33014
Cheryl Duggan
[email protected]
305-817-2900
Evolution Research Group, Clinical Pharmacology of Miami (CPMI)MiamiFlorida33172
Cheryl Duggan
[email protected]
305-817-2900

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Evolution Research Group, Clinical Pharmacology of Miami (CPMI)· Miami, FL

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