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
Aspargo Labs, Inc
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
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, di…
Eligibility
- Age range
- 18–55 years
- Sex
- Male
- Healthy volunteers
- Yes
Inclusion Criteria: * The participant must be informed of the nature of the study and voluntarily agree to participate by signing an informed consent form prior to any study-specific procedures. * Participants must be healthy male volunteers aged 18 to 55 years (inclusive) at the time of dosing. * Participants must have a body mass index between 18.0 and 29.9 kg/m² (inclusive) and a body weight of 50 to 100 kg (inclusive). * Participants must be judged by the Investigator or designee to be in good general health, as documented by medical history, physical examination, clinical laboratory test…
Interventions
- DrugASP-001
Oral liquid suspension of sildenafil
- DrugViagra
Sildenafil film-coated tablet
- DeviceASP-001
Bottle/pump containing ASP-001 suspension
Locations (2)
- Evolution Research Group, Clinical Pharmacology of Miami (CPMI)Miami, Florida
- Evolution Research Group, Clinical Pharmacology of Miami (CPMI)Miami, Florida