A Phase 1 Pharmacokinetic Study Comparing Hezkue® (ASP-001), Hezkue Turbo® (ASP-001.1), and Select Commercially Available Sildenafil Products Under Fed Conditions in Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Tmax - Time to Maximum Observed Plasma Concentration of Sildenafil
研究概览
简要总结
The goal of this clinical trial is to compare how different sildenafil formulations are absorbed and tolerated in healthy adult males under fed conditions. The main questions it aims to answer are:
Do Hezkue and Hezkue Turbo differ in absorption compared to other commercial sildenafil products?
Are there any differences in safety or tolerability between the products?
Researchers will compare multiple formulations to evaluate differences in drug absorption and side effects.
详细描述
The goal of this clinical trial is to learn how different formulations of sildenafil-used to treat erectile dysfunction-are absorbed in the body when taken with food, and to understand how safe and well-tolerated they are in healthy adult males. The main questions it aims to answer are:
How do the blood levels of sildenafil compare between Hezkue, Hezkue Turbo, and other commercial sildenafil products?
Do differences in formulation (such as particle size or combination with tadalafil) affect the absorption or safety profile?
Researchers will compare Hezkue and Hezkue Turbo to other sildenafil-containing products (such as Pfizer Viagra, BlueChew, and Ro Sparks) to see if there are differences in how quickly and how much of the drug enters the bloodstream.
Participants will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
- •Participant must be a healthy male, aged 18 to 70 years (inclusive) at the time of dosing.
- •Participant must be judged by the Investigator or designee to be in good general health, as documented by medical history, physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG). Any deviations from normal ranges must be assessed and deemed not clinically significant by the Investigator or designee.
- •Participant must have a creatinine clearance (CrCl) value greater than 80 mL/min, as calculated by the Cockcroft-Gault equation.
- •Participant must agree to practice an acceptable method of contraception throughout the clinical trial, as outlined in the protocol.
排除标准
- •Unwilling or unable to comply with study procedures.
- •Use of any investigational drug (except Hezkue/Hezkue Turbo) within 30 days prior to dosing.
- •History of significant renal, hepatic, cardiovascular (including orthostatic hypotension), psychiatric, neoplastic, infectious disease, or diabetes mellitus.
- •Clinically significant abnormal lab results, vital signs, or ECGs.
- •Any hepatic impairment or abnormal liver function tests.
- •Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- •Clinically significant illness within 28 days prior to dosing.
- •Known hypersensitivity to sildenafil, tadalafil, vardenafil, or any component of the investigational product (e.g., peppermint oil).
- •History of significant food or drug allergies.
- •History of drug abuse within the past year or positive drug screen at screening.
- •Regular alcohol consumption exceeding 15 units per week.
- •Use of CYP450 enzyme inhibitors within 14 days prior to dosing.
- •Use of CYP450 enzyme inducers or St. John's Wort within 28 days prior to dosing.
- •Blood donation or significant blood loss within 3 months before screening.
- •Plasma donation within 14 days prior to first dose.
- •Inadequate venous access for repeated blood sampling.
- •Difficulty fasting or inability to consume standardized meals.
- •Intolerance to fatty foods or inability to consume a high-fat, high-calorie breakfast.
- •Difficulty swallowing.
- •Regular use of tobacco or nicotine products within 4 weeks prior to screening.
- •Major surgery within 3 months or minor surgery within 1 month before screening.
- •Considered unsuitable for study participation by the Investigator.
- •Institutionalized status.
- •Use of hormone replacement therapy within 6 months prior to dosing.
- •Consumption of Seville oranges, grapefruit, or pomelo within 7 days prior to dosing.
- •Consumption of caffeine, xanthine-containing products, or poppy seeds within 48 hours prior to dosing.
- •Receipt of a COVID-19 vaccine within 3 days prior to dosing.
- •Presence of braces, retainers, dentures, partial dentures, or tongue piercings.
- •Use of nitric oxide donors, organic nitrates/nitrites, antihypertensive medications, or PDE5 inhibitors within 14 days of dosing.
- •Blood pressure or heart rate outside acceptable ranges:
- •Systolic BP <90 or >140 mmHg
- •Diastolic BP <50 or >90 mmHg
- •Heart rate <50 or >100 bpm
研究组 & 干预措施
Hezkue Formulations
Participants in this arm receive a single dose of 100mg (miligrams) of either Hezkue® (ASP-001) or Hezkue Turbo® (ASP-001.1), both liquid formulations containing sildenafil citrate.
干预措施: ASP-001.1 (Device)
Hezkue Formulations
Participants in this arm receive a single dose of 100mg (miligrams) of either Hezkue® (ASP-001) or Hezkue Turbo® (ASP-001.1), both liquid formulations containing sildenafil citrate.
干预措施: ASP-001 (Drug)
Commercially Available Sildenafil Products
Participants in this arm receive a single dose of one of several comparator products, including commercially available sildenafil tablets or sildenafil + tadalafil combination chewables.
干预措施: Commercial Sildenafil and Sildenafil/Tadalafil Products (Drug)
结局指标
主要结局
Tmax - Time to Maximum Observed Plasma Concentration of Sildenafil
时间窗: Baseline and up to 4 hours post-dose at 23 specified timepoints
Measurement of the time (Tmax) to reach maximum observed plasma concentration of sildenafil following a single oral dose under fed conditions.
Cmax - Maximum Observed Plasma Concentration of Sildenafil
时间窗: Baseline and at 23 timepoints within 4 hours post-dose.
Measurement of the maximum observed plasma concentration (Cmax) of sildenafil following a single oral dose of study drug.
次要结局
- Number of Participants Reporting Oral Irritation, Dizziness, or Headache(From pre-dose through 96 hours post-dose.)
- Number of Participants With Adverse Events(From pre-dose through 96 hours post-dose.)