ISRCTN45336965已完成未知
An open-label, randomized, two-period crossover study to explore the pharmacokinetics of diltiazem solution released from the IntelliCap as compared to a marketed diltiazem 60 mg extended release capsule in healthy volunteers
Medimetrics Personalized Drug Delivery B.V. (Netherlands)0 个研究点目标入组 14 人开始时间: 2014年2月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Provision of informed consent
- •2. Healthy male subjects age 18 to 45 years of age inclusive
- •3. Vital signs: body temperaturebetween 35.0 and 37.5 °C, systolic blood pressure 90-140 mmHg, diastolic blood pressure 60-90 mmHg, pulse rate 50-90 bpm
- •4. Body weight > 50 kg, BMI 18 to 29 kg/m2
排除标准
- •1. Smoking
- •2. Use of prescription drugs, herbal supplements, over the counter medication
- •3. Significant ECG (electrocardiogram) abnormalities
- •4. Surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs
- •5. Impaired renal function
- •6. Pacemakers or other implanted electro-medical devices
- •7. Swallowing disorder
- •8. Scheduled MRI assessment
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