NCT02446353已完成1 期
A Randomized, Open Label, Single Dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® Under Fasting and Fed Conditions in Healthy Male Volunteers
LG Life Sciences0 个研究点目标入组 79 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 主要终点
- Cmax
研究概览
简要总结
A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® in Healthy Male Volunteers.
详细描述
[Part 1] fasting [Part 2] fed
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
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Is a healty male between 20 and 55 years old.
- •In a ± 20% than ideal body weight. [ideal body weight(kg) = height(cm)-100) x 0.9 (Broca's rule)
- •Subjects who are considered to be suitable in conducting the clinical trial in serum test, hematology test, hemato-chemical test, urine test and 12-ECG result.
- •Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Agrees to use an adequate means of contraception during clinical trials
- •Subject who has voluntarily decided to participate in this clinical trial and consented in writing.
排除标准
- •Is allergic against Megestrol acetate or other drugs (Aspirin, NSAIDs, Antibiotics, etc.) or against foods, or has an clinically serious allergic history.
- •Subjects who have present condition or past history of any disease involving liver, kidney, nervous system, immune system, respiratory system, or endocrine system; hematologic and oncologic disease; cardiovascular disease; or psychiatric disorder (mood disorder, obsessive-compulsive disorder, etc. that may affect ADME of investigational medicinal products.
- •In the vital signs measured in sitting position at the screening visit, subjects who have hypertension desease(a systolic blood pressure of ≥ 150 mmHg or a diastolic blood pressure of ≥ 100 mmHg).
- •Diabetic patients or the patients who are abnormal of impaired glucose tolerance.
- •The patients who have a history of Arterial Embolism.
- •The patients who have a history of adrenal insufficiency like hypotension or nausea or vertigo or asthenia or etc.
- •Subjects who have a history of drug abuse or shown positive reaction to drugs that may be abused from a urine drug screening
- •Subjects who took any specialized drug or an herbal medication within 2 weeks before the date of first administration or took any over the counter (OTC) drug within 1 week (however, they may be included as subjects if appropriate depending on the investigator's discretion)
- •Subjects who had whole blood donation within 2 months or component blood donation within 1 month before the clinical trial.
- •Subjects who have abnormal diets that may affect ADME of investigational medicinal products.
- •Subjects who have been drinking extremely alcohol and caffeine (more than caffeine 5 cups/day, soju 3 cups/day, beer 3 cups/day, liquors 2 cups/day, 10 cigarettes/day) or can't refrain from drinking during the clinical trial period.
- •Subjects who had administration a barbiturates within 1 month before the date of first drug administration
- •Subjects who already participated in other clinical trials within 2 months before this clinical trial.
- •Subjects who are considered to be unsuitable in conducting the clinical trial for other reason at the principal investigator's discretionary judgment
研究组 & 干预措施
Megace : fed
Experimental
Megace / Apetrol ES : comparator / test, fed
干预措施: Apetrol ES / Megace (Drug)
Apetrol ES : fed
Experimental
Apetrol ES / Megace : test / comparator, fed, cross-over
干预措施: Apetrol ES / Megace (Drug)
Megace : fasting
Experimental
Megace / Apetrol ES : comparator / test, fasting
干预措施: Apetrol ES / Megace (Drug)
Apetrol ES : fasting
Experimental
Apetrol ES / Megace : test / comparator, fasting, cross-over
干预措施: Apetrol ES / Megace (Drug)
结局指标
主要结局
Cmax
时间窗: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
16 times(fasting), 15 times(fed)
AUClast
时间窗: Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h
16 times(fasting), 15 times(fed)
次要结局
- AUCinf, %AUCextra(Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h)
- Tmax(Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h)
- t1/2(Pre-dose(0h), 1, 2, 3, 4, 5, 6, (7), 8, 10, 12, 24, 48, 72, 96, 120 h)
研究者
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