NCT01353404已完成1 期
Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg) in Normal Healthy Subjects
Samyang Biopharmaceuticals Corporation1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年6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
- 24
- 试验地点
- 1
- 主要终点
- Bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg)
研究概览
简要总结
The purpose of this study is to evaluate the bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg) in single dose oral administration.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adults 20-50 years of age
- •Weight more than 55kg and within ±20% IBW(Ideal Body Weight)
- •Voluntary written informed consent
排除标准
- •History or presence of significant renal, neurologic, pulmonary, endocrine, hematology, oncology, urologic, cardiovascular, musculoskeletal or psychiatric disease
- •Drug allergies to fenofibrate
- •Recent history or evidence of drug abuse
- •Recent participation(within 2months) in other clinical studies
- •Recent donation of blood(within 2months) or plasma(within 1months)
研究组 & 干预措施
fenofibrate 65mg, fed condition, per oral
Experimental
干预措施: Sequence 1 (Drug)
fenofibrate 65mg, fed condition, per oral
Experimental
干预措施: Sequence 2 (Drug)
fenofibrate 65mg, fed condition, per oral
Experimental
干预措施: Seqeunce 3 (Drug)
fenofibrate 65mg, fed condition, per oral
Experimental
干预措施: Sequence 4 (Drug)
fenofibrate 65mg, fed condition, per oral
Experimental
干预措施: Sequence 5 (Drug)
fenofibrate 65mg, fed condition, per oral
Experimental
干预措施: Sequence 6 (Drug)
fenofibrate 65mg, fasting condition, per oral
Experimental
干预措施: Sequence 1 (Drug)
fenofibrate 65mg, fasting condition, per oral
Experimental
干预措施: Sequence 2 (Drug)
fenofibrate 65mg, fasting condition, per oral
Experimental
干预措施: Seqeunce 3 (Drug)
fenofibrate 65mg, fasting condition, per oral
Experimental
干预措施: Sequence 4 (Drug)
fenofibrate 65mg, fasting condition, per oral
Experimental
干预措施: Sequence 5 (Drug)
fenofibrate 65mg, fasting condition, per oral
Experimental
干预措施: Sequence 6 (Drug)
fenofibrate 160mg, fed condition, per oral
Active Comparator
干预措施: Sequence 1 (Drug)
fenofibrate 160mg, fed condition, per oral
Active Comparator
干预措施: Sequence 2 (Drug)
fenofibrate 160mg, fed condition, per oral
Active Comparator
干预措施: Seqeunce 3 (Drug)
fenofibrate 160mg, fed condition, per oral
Active Comparator
干预措施: Sequence 4 (Drug)
fenofibrate 160mg, fed condition, per oral
Active Comparator
干预措施: Sequence 5 (Drug)
fenofibrate 160mg, fed condition, per oral
Active Comparator
干预措施: Sequence 6 (Drug)
结局指标
主要结局
Bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg)
时间窗: 23 days
次要结局
未报告次要终点
研究者
研究点 (1)
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