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

Inclusion Criteria:

• The participant must be informed of the nature of the study and voluntarily agree toparticipate by signing an informed consent form prior to any study-specificprocedures.

• Participants must be healthy male volunteers aged 20 to 70 years (inclusive) at thetime of dosing.

• Participants must have a body mass index between 18.0 and 29.9 kg/m² (inclusive) anda body weight of 50 to 100 kg (inclusive).

• Participants must be judged by the Investigator or designee to be in good generalhealth, as documented by medical history, physical examination, clinical laboratorytests, vital signs, and 12-lead electrocardiogram (ECG). Any deviations from normalranges must be assessed and deemed not clinically significant by the Investigator ordesignee.

• Participants must have a creatinine clearance (CrCl) value greater than 80 mL/min,as calculated by the Cockcroft-Gault equation.

• Participants must agree to practice an acceptable method of contraception asoutlined in the protocol.

Exclusion Criteria:

• Unwillingness or inability to follow the procedures specified by the protocol.

• Participant received any investigational drug/product within 30 days prior to thefirst dose.

• History of significant renal, hepatic, cardiovascular (including orthostatichypotension), psychiatric, neoplastic, inflammatory, infectious, diabetes mellitus,or other disease which, in the opinion of the Investigator, represents a safety riskfor taking part in the study.

• Presence of any clinically significant results from laboratory tests, vital signsassessments, and electrocardiograms, as judged by the Investigator and/or designee.

• Any degree of hepatic impairment based on liver function testing (abnormal ALT, AST,bilirubin, alkaline phosphatase, prothrombin time and international normalized ratioduring screening).

• Demonstrates a reactive screen for hepatitis B surface antigen, hepatitis Cantibody, or HIV antibody.

• Reports a clinically significant illness during the 28 days prior to first dose (asdetermined by the Investigator and/or designee).

• Subjects with known hypersensitivity to sildenafil or any component in the studymedication, such as peppermint oil.

• Reports a history of clinically significant allergies including food or drugallergies as judged by the Investigator.

• History of drug abuse within the previous year, or a positive drug screen (amphetamines, barbiturates, benzodiazepines, cannabinoids, Cocaine, Opiates,Phencyclidine, 3,4-methylenedioxymethamphetamine (MDMA)) at screening and/or Day -1.

• Regular alcohol consumption of >15 units per week, with one unit being equivalent to 330 mL of beer or 125 mL of wine or 25 mL to 40 mL of ≥ 40% spirits, or a positivealcohol breathalyzer test at screening and/or Day -1.

• Reports use of CYP enzyme inhibitors within 14 days prior to Period 1 dosing.

• Reports use of CYP enzyme inducers or St. John's Wort within 28 days prior to Period 1 dosing.

• Use of prescription or non-prescription drugs, including individual vitamins, herbaland dietary supplements within seven days or five half-lives, whichever is longer,unless in the opinion of the Investigator and Sponsor's medical monitor themedication is not expected to interfere with the study procedures or compromisesubject safety (occasional use of acetaminophen, naproxen, and ibuprofen areallowed).

• Blood donation or significant blood loss within 3 months before screening. Allvolunteers will be advised not to donate blood for 30 days after completing thestudy.

• Reports donating plasma within 14 days prior to first dose. All volunteers will beadvised not to donate plasma for 30 days after completing the study.

• Demonstrates, in the opinion of study staff, inadequate veins or veins unsuitablefor repeated venipuncture (e.g., veins difficult to locate, access, or puncture;veins with a tendency to rupture during or after puncture).

• Reports difficulty fasting or consuming standardized meals.

• Reports intolerance to fatty foods or cannot consume a high-calorie and high-fatbreakfast.

• Subjects who have difficulty swallowing.

• Regular use of tobacco (>4 cigarettes per day) or nicotine-containing productswithin four weeks before screening, or urinary cotinine level indicative of activesmoking at screening and/or Day -1

• Major surgery within three months or minor surgery within one month before screeningas per the Principal Investigator (PI) judgment.

• If, in the opinion of the PI, the subject is not suitable for the study.

• Subject administered COVID-19 vaccine within three days prior to each check-in.

• Subjects with retainers, braces, dentures, partial dentures, and/or tongue piercing.

• Subjects using the following within 14 days of first dose:

• Nitric oxide donors, such as organic nitrates or organic nitrites in any form

• Antihypertensive medications

• PDE5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)

Subjects with known hypertension or blood pressure and heart rate outside of the following ranges:

• Systolic blood pressure: 90 - 140 mmHg

• Diastolic blood pressure: 50 - 90 mmHg

• Heart rate at screening: 50 - 100 beats per minute

• Institutionalized volunteers.

• Reports use of any hormone replacement therapy within 6 months prior to first dose.

• Use of any products containing Seville oranges, grapefruit and pomelo within sevendays prior to first dose and for the duration of the study.

• Ingestion of any caffeine/xanthine containing products (coffee, tea, soft drinks,chocolate, energy drinks, etc.), foods containing poppy seeds within 48 hours priorto first dose and for the duration of the study.

• Ingestion of any beverages containing more than 5% fruit juice (fruit drinks, fruitpunches, fruit cocktails, fruit-ades, or other products containing 5% or less offruit juice will be allowed) within 48 hours prior to first dose and for theduration of the study.