Phase 2 Crossover Study Assessing the Effect of Moderate Alcohol Intake on the Absorption and Onset of Action of Hezkue® Sildenafil Oral Suspension
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 主要终点
- Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Sildenafi
研究概览
简要总结
This is a Phase 2, open-label, randomized crossover study assessing the effect of moderate alcohol intake on the absorption and onset of action of Hezkue® sildenafil oral suspension in adult subjects. Participants will receive Hezkue® under different alcohol intake conditions in randomized sequence. Pharmacokinetic sampling and onset assessments will be performed after each administration, and safety will be monitored throughout the study.
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
- 否
入选标准
- •Male adults 21 to 65 years of age, inclusive
- •Documented history of erectile dysfunction for at least 6 months, as determined by the investigator
- •In a stable sexual relationship and willing to attempt sexual activity as required by study procedures, if applicable
- •Medically stable based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator
- •Able, in the investigator's judgment, to safely consume moderate amounts of alcohol as defined in the protocol
- •Willing to abstain from alcohol outside of protocol-specified intake during the study
- •Able to understand and provide written informed consent before any study-specific procedures are performed
- •Willing and able to comply with all study procedures, including dosing, washout periods, pharmacokinetic sampling, onset assessments, and safety monitoring
排除标准
- •Known hypersensitivity or contraindication to sildenafil, other PDE5 inhibitors, alcohol, or any component of the Hezkue® formulation
- •Use of nitrates, nitric oxide donors, guanylate cyclase stimulators (such as riociguat), or other prohibited medications within a protocol-defined period
- •Clinically significant cardiovascular disease, including coronary artery disease, heart failure, clinically important arrhythmias, recent stroke, or uncontrolled hypertension or hypotension
- •Resting blood pressure or heart rate outside protocol-defined acceptable ranges at screening or baseline, in the opinion of the investigator
- •Significant hepatic, renal, neurologic, psychiatric, endocrine, hematologic, or respiratory disease that could increase risk or interfere with study assessments
- •History of syncope, significant orthostatic hypotension, or other conditions that may be worsened by sildenafil or alcohol
- •History of alcohol use disorder, binge drinking, or other substance use disorder, as determined by the investigator
- •Positive urine drug screen or positive alcohol test at screening or admission (outside protocol-specified alcohol administration)
- •Use of prescription or over-the-counter medications, herbal products, or dietary supplements within 14 days before first dosing unless approved 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 product within 30 days or 5 half-lives, whichever is longer
- •Donation of 450 mL or more of blood, or significant blood loss, within 8 weeks before first dosing
- •Any condition or circumstance that, in the opinion of the investigator, would make the participant unsuitable or interfere with study conduct or interpretation
研究组 & 干预措施
Single-Arm Crossover
干预措施: Hezkue Sildenafil Oral Suspension (Drug)
Hezkue® With Moderate Alcohol Intake
Participants will receive Hezkue® sildenafil oral suspension administered following standardized moderate alcohol intake in one study period. Pharmacokinetic, absorption, onset of action, and safety assessments will be conducted following dosing.
干预措施: Hezkue Sildenafil Oral Suspension (Drug)
Hezkue® With Moderate Alcohol Intake
Participants will receive Hezkue® sildenafil oral suspension administered following standardized moderate alcohol intake in one study period. Pharmacokinetic, absorption, onset of action, and safety assessments will be conducted following dosing.
干预措施: Moderate Alcohol Intake (Other)
结局指标
主要结局
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Sildenafi
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 Erectile Response
时间窗: From dosing up to approximately 4 hours postdose in each study period
次要结局
未报告次要终点