A Phase 1 Food-Effect Study of 100 mg of 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
Aspargo Labs, Inc
Summary
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
Description
This is a Phase 1, open-label, single-center, two-period, two-treatment crossover study designed to evaluate the pharmacokinetics (PK), food effect, safety, and tolerability of ASP-001.1 (oral liquid suspension of sildenafil) under fed versus fasted conditions in healthy adult male participants. The crossover design ensures that each participant receives ASP-001.1 under both fed and fasted conditions, allowing for direct within-subject comparison of the pharmacokinetic parameters. The study aims to determine the effect of food on the absorption and bioavailability of ASP-001.1 and to assess it…
Eligibility
- Age range
- 20–70 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 20 to 70 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-001.1
Oral liquid suspension of sildenafil
- DeviceASP-001.1
Bottle/pump containing ASP-001.1 suspension
Location
- Aspargo LabsNew York, New York