NCT02988362已完成1 期
An Open-label, Randomized, Cross-over Study to Evaluate Pharmacokinetics and the Safety of HL068 16/10mg Compared to Candesartan 16mg and Amlodipine 10mg Co-administered 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
- 42
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this study is to compare the safety and pharmacokinetics of HL068 (Candesartan 16 mg and Amlodipine 10mg) with coadministration of the two separate drugs 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
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteer in the age between 19 and 55 years old.
- •Body mass index (BMI) in the range of 18.5 to 27.0 kg/m2
- •Understand the requirements of the study and voluntarily consent to participate in the study.
排除标准
- •Previous history or present of clinically significant digestive , cardiovascular, respiratory, psychiatric, endocrine, hepatobiliary, renal disease.
- •History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
- •Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •Subjects whose clinical laboratory test values are outside the accepted normal range. Especially, ASTor ALT >1.5 times of the Upper Normal Limit or total bilirubin > 1.5 times of the Upper Normal Limit
- •Positive test results for Hepatitis B antibodies, Hepatitis C virus antibody, and Syphilis regain test
- •Participation in any clinical investigation within 3 months prior to study drug administration
- •Subjects with whole blood donation within 60 days or component blood donation within 30days or blood transfusion within 30days prior to the first dosing.
- •SBP ≥ 140 mmHg or< 115 mmHg, DBP ≥ 90 mmHg or < 70 mmHg
- •Caffeine > 400mg/day
- •Alcohol > 30g/day
- •Cigarette > 10 cigarettes/day.
- •Subjects who are judged unsuitable by investigators
研究组 & 干预措施
Candesartan 16mg and Amlodipine 10mg
Experimental
Candesartan 16mg and Amlodipine 10mg
干预措施: Candesartan 16mg and Amlodipine 10mg (Drug)
HL068
Experimental
HL068(combination of Candesartan 16 mg and Amlodipine 10 mg)
干预措施: HL068 16/10mg (Drug)
结局指标
主要结局
Cmax
时间窗: up to 72 hours
AUCt
时间窗: up to 72 hours
次要结局
- Tmax(up to 72 hours)
- t 1/2β(up to 72 hours)
- AUCinf(up to 72 hours)
- CL/F(up to 72 hours)
研究者
相似试验
已完成
1 期
CKD-330 Drug-Drug Interaction Study (Candesartan)HypertensionNCT02064621Chong Kun Dang Pharmaceutical24
已完成
4 期
Efficacy and Safety of Valsartan, Hydrochlorothiazide and Amlodipine Combination Therapy in HypertensionHypertensionNCT00400777Novartis460
终止
4 期
The Study to Evaluate Efficacy and Safety of Candesartan vs Losartan in Hypertension With Heart Failure (HONOR)HypertensionNCT01766505Chong Kun Dang Pharmaceutical32
已完成
1 期
Evaluating a Pharmacokinetic Drug Interaction Between HGP0918 and HGP0816HealthyNCT02554136Hanmi Pharmaceutical Company Limited36
已完成
4 期
Efficacy and Safety of Candesartan Cilexetil Plus Hydrochlorothiazide in Subjects With Severe HypertensionHypertensionNCT01012479Takeda107