Study to Compare the Effects of Viagra® Vs Hezkue® in Healthy Fasted Male Participants.
NCT06782659 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2025-01-20
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
Conditions
Interventions
- DRUG
-
ASP-001
Oral liquid suspension of sildenafil
- DRUG
-
Viagra
Sildenafil film-coated tablet
- DEVICE
-
ASP-001
Bottle/pump containing ASP-001 suspension
Sponsors & Collaborators
-
Aspargo Labs, Inc
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-01-31
- Primary Completion
- 2025-03-31
- Completion
- 2025-03-31
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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