NCT01494727已完成1 期
A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet After a Single Oral Administration in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
研究概览
简要总结
The objectives of this study are:
- To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
- To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male volunteers in the age between 20 and 45 years old
- •Body Mass Index (BMI) in the range of 19 to 27 kg/m2
排除标准
- •History of allergy or sensitivity to any drug, including amlodipine or valsartan
- •History of clinically significant hepatic, renal, gastrointestinal, neurology, pulmonary, endocrine, musculoskeletal, hematologic, oncologic, psychiatric, especially cardiovascular disease
- •History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
- •Hypotension (Systolic Blood Pressure(SBP) ≤ 100 mmHg or Diastolic Blood Pressure(DBP) ≤ 65 mmHg)
- •Hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg)
- •Clinical laboratory test values are outside the accepted normal range
- •Aspartate Transaminase(AST) or Alanine Transaminase(ALT) > 1.25 times to normal range
- •Total bilirubin > 1.25 times to normal range
- •Positive for Hepatitis B Virus surface Antigen(HBsAg), Hepatitis C Virus Antibody(HCVAb) or Human Immunodeficiency Virus Antibody(HIVAb)
研究组 & 干预措施
CJ Amlodipine/Valsartan 10/160mg
Experimental
干预措施: CJ Amlodipine/Valsartan 10/160mg (Drug)
Novartis Exforge 10/160mg
Active Comparator
干预措施: Novartis Exforge 10/160mg (Drug)
研究者
研究点 (1)
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