| 伊拉地平胶囊I期临床安全性和耐受性评价 |
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| 引用本文： | 朱孔彩,薛薇,谢潘潘,史爱欣,胡欣,李扬,李敏,严蓓,迟家敏,董凡,李康,曹国颖.伊拉地平胶囊I期临床安全性和耐受性评价[J].中国药学,2014,23(3):194-198. |
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| 作者姓名： | 朱孔彩 薛薇 谢潘潘 史爱欣 胡欣 李扬 李敏 严蓓 迟家敏 董凡 李康 曹国颖 |
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| 作者单位： | [1]北京大学医学部药学院药事管理与临床药学系,北京100191 [2]北京大学第五临床医学院北京医院,北京100730 [3]沈阳药科大学药学院,沈阳110016 |
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| 摘 要： | 本文旨在评价国产伊拉地平胶囊在中国健康受试者体内的耐受性和安全性。单次给药的剂量递增顺序依次为2.5 mg,5 mg,10 mg。其中5 mg剂量组的受试者在完成单次给药试验后需继续留在研究中心,进行多次给药试验。医学观察指标包括生命体征、心电图、水肿及医学实验室检查。结果显示单次给药各组受试者的血压在服药后均有下降趋势。不良事件主要包括头痛、面部潮红、皮肤瘙痒和转氨酶升高。因此,按照试验设计的给药剂量和方案,受试者对伊拉地平有较好的耐受性。
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| 关 键 词： | 伊拉地平胶囊 耐受性 安全性 I期临床试验 |
Safety and tolerability of isradipine in Phase I trial in Chinese population |
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| Kongcai Zhu,Wei Xue,Panpan Xie,Aixin Shi,Xin Hu,Yang Li,Min Li,Bei Yan,Jiamin Chi,Fan Dong,Kang Li,Guoying Cao.Safety and tolerability of isradipine in Phase I trial in Chinese population[J].Journal of Chinese Pharmaceutical Sciences,2014,23(3):194-198. |
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| Authors: | Kongcai Zhu Wei Xue Panpan Xie Aixin Shi Xin Hu Yang Li Min Li Bei Yan Jiamin Chi Fan Dong Kang Li Guoying Cao |
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| Affiliation: | 1. Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing 100191, China 2. Department of Pharmacy, the Fifth Clinical Medical College of Peking University, Beij＇ing Hospital Beijing 100730, China 3. School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China) |
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| Abstract: | Hypertension is one of the well-established risk factor for cardiovascular diseases. Calcium channel blockers（CCBs）, chemicals that could block voltage-gated calcium channels（VGCCs） in cardiac muscle and blood vessels, has been widely used for the treatment of hypertension. Isradipine, a second-generation CCB with high affinity for voltage-operated calcium channels, has not been marked in China. The purpose of this study was to investigate the efficacy, safety and tolerability of isradipine in a phase I clinical trial including 31 healthy Chinese subjects. All subjects received different doses of isradipine at 2.5, 5.0 and 10.0 mg in single-dose study. When the test is completed, subjects treated with 5.0 mg isradipine stayed at the research center for multiple-dose study（5.0 mg isradipine twice daily for 9 d）. Systolic blood pressure（SBP） and diastolic blood pressure（DBP） were measured pre-dose and post-dose（1, 2, 4, 6, 8, 12, 24, 36 and 48 h after isradipine treatment）. Electrocardiography（ECG） and peripheral edema were monitored pre-dose and 4, 8, 24 and 48 h after isradipine treatment. SBP and DBP in single-dose study decreased after isradipine treatment. SBP reached the lowest values 8 h after dosing with a decrease of（7.0±9.7） mmHg（5.4%, P = 0.111） in 2.5 mg group,（7.0±6.9） mmHg（6.0%, P = 0.008） in 5.0 mg group, and（14.0±10.5） mmHg（12.7%, P = 0.005） for 10.0 mg group respectively. Similarly, DBP also reached the lowest values 8 h after dosing with a decrease of（10.0±7.9） mmHg（12.8%, P = 0.004） in 2.5 mg group,（6.0±7.0） mmHg（8.6%, P = 0.003） in 5.0 mg group, and（11.0±4.1） mmHg（15.1%, P = 0.000） in 10.0 mg group respectively. No significant changes of SBP and DBP were observed in multiple-dose study. We detected mild adverse events（AEs）, such as increased transaminase and headache that resolved rapidly and spontaneously without intervention. No serious or potentially life-threatening AE was detected. Our results indicate that isradipin has a good safety and tolerability in Chinese healthy subjects. Long-term study with larger sample size is needed to confirm our conclusion. |
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| Keywords: | Isradipine capsule Tolerance Safety Phase I clinical trial |
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