Pharmacokinetics and Pharmacodynamics of Sildenafil in Adult Smokers and Non-smokers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Maximum drug concentration in plasma (Cmax)
研究概览
简要总结
Smokers are at higher risk of developing Erectile dysfunction (ED) independent of age and comorbidities. Sildenafil is a cytochrome p3A4 (CYP3A4) substrate used for enhancing the erectile function in males. The study purpose is to determine the effect of smoking on male sexual function based on the international index of erectile function score (IIEF) and investigate the effect of smoking (Cigarettes or marijuana) on the pharmacokinetics and pharmacodynamics of sildenafil.
详细描述
The study is a randomized, single dose, one way, open label, parallel study in thirty-six (36) subjects randomized into three groups;group(1) included twelve(12) healthy non-smoker males, group(2) included twelve(12) healthy smokers (Cigarettes) and group(3) included twelve(12) healthy smokers (marijuana).
Each group received a single dose of Viagra 50 mg film coated tablet (Sildenafil 50 mg) Blood samples were collected at the following sampling intervals: pre-dose administration, 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8,10, 12 and 24 hours post dose.
Blood samples were centrifuged and plasma was separated and stored at -80 degree Celsius till time of analysis.
Plasma concentrations of sildenafil were determined by liquid chromatography tandem mass spectrometry (LC/MS/MS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects
- •Age 18-55 years.
- •Ideal weight with ideal body mass index(BMI).
- •Non-contributory history and normal physiological examination.
- •Laboratory data within normal limits.
- •Performance and compliance.
- •The subjects should be without known history of alcohol or drug abuse problems
- •Subjects who are cigarette smokers
- •Subjects who are cannabis smokers
- •Subjects who are non-smokers
排除标准
- •A known hypersensitivity to the drug.
- •Gastrointestinal diseases.
- •Auto immune diseases.
- •Renal diseases or dysfunction.
- •Cardiovascular disease of any type.
- •Pancreatic disease including diabetes.
- •Hepatic disease.
- •Hematological, osteopathic, or pulmonary disease.
- •History of alcoholism or drug abuse.
- •Serious Psychological illness.
- •Positive HIV.
- •Abnormal (out of range) laboratory values.
- •Subject who have taken any medication less than two weeks of the trials starting date.
- •Subject who have donated blood or who have been in multiple dosing studies requiring a large volume of blood (more than 500 ml) to be drawn within six weeks preceding the start of the trials.
研究组 & 干预措施
Non-Smokers
Subjects administer one tablet of sildenafil 50 mg
干预措施: Sildenafil 50 mg Oral Tablet (Drug)
Cigarette Smokers
Subjects administer one tablet of sildenafil 50mg
干预措施: Sildenafil 50 mg Oral Tablet (Drug)
Cannabis Smokers
Subjects administer one tablet of sildenafil 50mg
干预措施: Sildenafil 50 mg Oral Tablet (Drug)
结局指标
主要结局
Maximum drug concentration in plasma (Cmax)
时间窗: up to 3 hours post-dose
Maximum drug concentration in plasma measured in nano-grams per milliliters (ng/ml)
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration post-dose (AUC0→t)
时间窗: up to 24 hours post-dose
Area under the plasma concentration-time curve from time 0 to time(t) measured in nano-grams multiplied by hours and divided by milliliters (ng.h/ml)
次要结局
- Time to Maximum drug concentration in plasma (tmax)(up to 3 hours post-dose)
- Area under the plasma concentration-time curve from time 0 to infinity(Up to 24 hours post-dose)
- Elimination half life of drug in plasma ( t½)(Up to 24 hours post-dose)
研究者
Mohamed Raslan
QC Manager and Clinical pharmacy Msc student
Drug Research Centre, Cairo, Egypt