Aspargo Labs, Inc
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
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…
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…
Oral liquid suspension of sildenafil
Bottle/pump containing ASP-001.1 suspension
Arctuva estimate
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