Actively Recruiting

Phase 1
Age: 20Years - 70Years
MALE
Healthy Volunteers
NCT06872866

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

Led by Aspargo Labs, Inc · Updated on 2025-11-19

12

Participants Needed

1

Research Sites

45 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years - 70Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male volunteers aged 20 to 70 years at dosing
  • Body mass index between 18.0 and 29.9 kg/m² and body weight between 50 and 100 kg
  • Good general health based on medical history, physical exam, lab tests, vital signs, and ECG
  • Creatinine clearance greater than 80 mL/min
  • Voluntary informed consent and agreement to contraception practice
Not Eligible

You will not qualify if you...

  • Unwillingness or inability to follow study procedures
  • Use of investigational drugs within 30 days before dosing
  • Significant renal, hepatic, cardiovascular, psychiatric, neoplastic, inflammatory, infectious, or diabetic conditions
  • Clinically relevant abnormal lab tests, vital signs, or ECG
  • Hepatic impairment or reactive screening for hepatitis B, C, or HIV
  • Illness within 28 days prior to dosing
  • Known allergy to sildenafil or components like peppermint oil
  • History of drug abuse within one year or positive drug screen
  • Regular alcohol use over 15 units per week or positive alcohol breath test
  • Use of CYP enzyme inhibitors or inducers within specified timeframes
  • Use of medications, supplements within 7 days unless deemed safe
  • Recent blood or plasma donation
  • Unsuitable veins for repeated blood draws
  • Difficulty fasting or consuming standardized meals
  • Intolerance to fatty foods or difficulty swallowing
  • Regular tobacco or nicotine use within 4 weeks or positive cotinine test
  • Recent major or minor surgery
  • COVID-19 vaccination within 3 days prior to check-in
  • Use of retainers, braces, dentures, or tongue piercing
  • Use of nitric oxide donors, antihypertensives, or PDE5 inhibitors within 14 days
  • Blood pressure or heart rate outside specified ranges
  • Institutionalized individuals
  • Use of hormone replacement therapy within 6 months
  • Consumption of Seville oranges, grapefruit, pomelo, caffeine, poppy seeds, or beverages with over 5% fruit juice within specified times before dosing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Aspargo Labs

New York, New York, United States, 10004

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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