A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety Profile and Pharmacokinetic Parameters of Udenafil 150 mg in Healthy Mexican Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 主要终点
- Participants with Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of Udenafil 150 mg compared to placebo.
详细描述
The drug being tested in this study is called Udenafil. Udenafil is being tested to determine a safe and well-tolerated dose. This study will look at vital signs, laboratory tests and side effects in people who take Udenafil.
The study will enroll approximately 84 patients. Participants will be randomly assigned (by chance) and by blocks to assure balanced groups (i.e. same number of participants) to one of the four treatment schemes-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- a) Udenafil-Udenafil
- b) Udenafil- Placebo
- c) Placebo-Udenafil
- d) Placebo-Placebo
All participants will be asked to take one tablet on Day 1 and one tablet on Day 3.
This single-centre trial will be conducted in Mexico. The overall time to participate in this study is up to 7 days. Participants will make 3 visits to the clinic, including 5 days confinement to the clinic, and will be contacted by telephone 15 days after last visit to the clinic for a follow-up assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Sign a letter of informed consent prior to performing any procedure.
- •Clinically healthy
- •Age between 18 and 55 years old.
- •Body Mass Index (BMI) between 18.5 and 24.
- •Capability and disposition to attend clinical intervention period
排除标准
- •Current use of any allopathic, over the counter (OTC) (e.g. nutritional supplements) or alternative (e.g. herbal) medication within two weeks prior to trial initiation.
- •History of psychiatric diseases.
- •History of drug abuse (alcohol, tobacco or any other).
- •Chronic consumption of caffeine (coffee, cola, green tea, St. Johns Wort).
- •Laboratory tests with clinically significant alterations.
- •Intestinal disorders that may modify absorption.
- •History of allergy to the drug or related drugs.
- •Blood donation within 45 days prior to study initiation.
- •Participation in a clinical trial within 2 months prior to study initiation.
- •History of orthostatic alterations or presyncope.
- •Vegetarian diet or other peculiar dietary habits which would interfere the participant's acceptance to standardized meals.
- •Inability to communicate or social vulnerability.
研究组 & 干预措施
Placebo + Udenafil 150 mg
Placebo, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3.
干预措施: Udenafil (Drug)
Udenafil 150 mg + Udenafil 150 mg
Udenafil 150 mg, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3.
干预措施: Udenafil (Drug)
Udenafil 150 mg + Placebo
Udenafil 150 mg, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3.
干预措施: Udenafil (Drug)
Udenafil 150 mg + Placebo
Udenafil 150 mg, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3.
干预措施: Placebo (Drug)
Placebo + Udenafil 150 mg
Placebo, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3.
干预措施: Placebo (Drug)
Placebo + Placebo
Placebo, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3.
干预措施: Placebo (Drug)
结局指标
主要结局
Participants with Adverse Events
时间窗: 3 Weeks
AEs will be evaluated by monitoring participants vital signs, laboratory tests (blood chemistry, hematology, coagulation and serology tests, urianalysis), electrocardiography (ECG).
次要结局
- Cmax: Maximum Observed Plasma Concentration(Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose)
- Tmax: Time to Reach the Maximum Plasma Concentration(Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose)
- Terminal Phase Elimination Half-life (T1/2)(Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose)
- AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity(Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose)
- AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measured Concentration Above the Lower Limit of Quantification(Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose)