NCT06074016已完成1 期
Pharmacokinetic Model Based on Population Physiology of Oral and Intranasal Formulations of Zolmitriptan in Healthy Volunteers
Parc de Salut Mar2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年7月12日最近更新:
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
- 8
- 试验地点
- 2
- 主要终点
- Effects of zolmitriptan on heart rate (HR).
研究概览
简要总结
This is a phase I study to evaluate the PBPK of zolmitriptan intranasal versus 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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female volunteers by physical examination, vital signs, ECG, and safety laboratory parameters and results must be within normal ranges or considered not clinically relevant by the investigator.
- •Age ≥ 18 years and ≤ 55 years.
- •Body mass index (BMI) ≥ 18 and ≤
- •Able/willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine-containing items when outside the Clinical Research Unit (CRU)
- •Able to read Spanish and adhere to study requirements.
- •Informed consent signed before any procedure required by the study.
排除标准
- •History or clinically relevant diseases.
- •Be under administrative or legal supervision.
- •Pregnancy and breastfeeding.
- •Positive blood or urine drug of abuse test or breathalyzer prior to study drug administration.
- •Any history, disease, disorder, condition, anomaly or clinical finding that is relevant in the judgment of the investigator that may interfere with the study.
- •Known hypersensitivity to any drug or excipient of the drug.
- •Use of medications, inhibitors, any prescription or over-the-counter products, including herbs, homeopathy, vitamins, minerals, and nutritional supplements, before or during the study, that may interfere with the conduct and results of the study.
- •Donation or transfusion of blood or plasma before, during or after study drug administration.
- •History of inadequate venous access and/or experience of difficulty donating blood.
- •Not being able/unwilling to accept restrictions regarding diet, physical exercise and consumption of alcohol and/or articles containing xanthine when outside the CRU.
- •Subject included in a clinical study in the 3 months prior to the study drug administration.
研究组 & 干预措施
Zolmitriptan intranasal.
Experimental
干预措施: Zolmitriptan intranasal. (Drug)
Zolmitriptan oral.
Experimental
干预措施: Zolmitriptan oral. (Drug)
结局指标
主要结局
Effects of zolmitriptan on heart rate (HR).
时间窗: Up to 24 hours.
Effects of zolmitriptan on systolic and diastolic blood pressure (BP).
时间窗: Up to 24 hours.
次要结局
- Concentration of zolmitriptan on vasoactive intestinal polypeptide (VIP) in captures Day 1.(Up to 24 hours.)
研究者
研究点 (2)
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