NCT07302698尚未招募1 期
Evaluation of the Pharmacokinetics and Onset Performance of Hezkue® Oral Sildenafil Suspension Following Alcohol Consumption in Healthy Adults
Aspargo Labs, Inc0 个研究点目标入组 24 人开始时间: 2026年3月15日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Sildenafil
研究概览
简要总结
This is an open-label, randomized study evaluating the pharmacokinetics and onset performance of Hezkue® oral sildenafil suspension administered following moderate alcohol consumption in healthy adult subjects. Participants will receive Hezkue® under controlled alcohol-exposure conditions. Pharmacokinetic sampling, onset assessments, and safety evaluations will be conducted throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Male or female adults 21 to 55 years of age, inclusive.
- •Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive.
- •Medically healthy based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator.
- •Able to safely consume moderate amounts of alcohol as judged by the investigator (for example, no history of alcohol intolerance, alcohol use disorder, or alcohol-related medical complications).
- •Blood pressure and heart rate within normal or non-clinically significant ranges at screening and baseline, in the opinion of the investigator.
- •Non-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during study confinement periods.
- •Able to understand and provide written informed consent before any study-specific procedures are performed.
- •Willing and able to comply with all study requirements, including alcohol restrictions, fasting, dosing schedules, and pharmacokinetic and onset assessments.
- •Females of childbearing potential must use acceptable contraception as determined by the investigator.
排除标准
- •History or presence of any clinically significant cardiovascular disease, including but not limited to coronary artery disease, heart failure, clinically important arrhythmias, or uncontrolled hypertension or hypotension.
- •Resting systolic blood pressure or diastolic blood pressure, or heart rate, outside protocol-defined acceptable ranges at screening or baseline, in the opinion of the investigator.
- •Known hypersensitivity or contraindication to sildenafil, other phosphodiesterase type 5 (PDE5) inhibitors, alcohol, or any component of the study formulations.
- •Current or recent use of nitrates, nitric oxide donors, or guanylate cyclase stimulators (for example, riociguat).
- •History of significant hepatic, renal, gastrointestinal, neurologic, psychiatric, endocrine, hematologic, or respiratory disease that, in the investigator's opinion, could interfere with study participation or data interpretation.
- •History of syncope, significant orthostatic hypotension, or other conditions that may be worsened by sildenafil or alcohol.
- •History of alcohol use disorder, binge drinking patterns, or other substance use disorder, as determined by the investigator.
- •Positive urine drug screen or positive alcohol test at screening (outside scheduled alcohol administration for the study) or at admission.
- •Use of prescription or over-the-counter medications, herbal products, or dietary supplements within 14 days before the first study dose, unless considered acceptable by the investigator.
- •Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.
- •Participation in another clinical study or receipt of an investigational drug or device within 30 days or 5 half-lives (whichever is longer) before the first study dose.
- •Donation of 450 mL or more of blood, or significant blood loss, within 8 weeks before the first study dose.
- •Pregnant or breastfeeding females.
- •Women of childbearing potential not using acceptable contraception.
- •Any condition or circumstance that, in the opinion of the investigator, would make the participant unsuitable for the study or could interfere with compliance or study assessments.
研究组 & 干预措施
Single-Arm Crossover
Experimental
干预措施: Hezkue Oral Sildenafil Suspension (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Sildenafil
时间窗: From predose up to approximately 24 hours postdose in each study period
Time to Onset of Effect as Assessed by Participant-Reported Onset
时间窗: From dosing up to approximately 4 hours postdose in each study period
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Sildenafil
时间窗: From predose up to approximately 24 hours postdose in each study period
次要结局
未报告次要终点
研究者
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