A Phase I Open Label Study to Assess the Single Dose Pharmacokinetics and Safety of Sublingual Administration of Tablets and Medicated Drops of Plant Cannabis Extract

Breath of Life International Pharma Ltd1 个研究点分布在 1 个国家目标入组 76 人开始时间: 2019年7月24日最近更新: 2022年12月8日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Breath of Life International Pharma Ltd
入组人数: 76
试验地点: 1
主要终点: Pharmacokinetic analysis of T1/2

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is an open-label, single-dose, healthy volunteer phase 1 study after overnight fasting designed to study the safety and PK of medicated drops and tablet formulation for sublingual administration.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Other
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy, male or female, between 18 and 45 years of age (inclusive).
•Body mass index (BMI) between 20-30 kg/m2 (both inclusive)
•No recent cannabis usage within 30 days from screening
•Normal rage hepatic functions
•No electrolytes abnormalities
•Vital signs at screening (after five minutes resting measured in the supine position) within the following ranges:
•Body temperature between 35.0 to 37.5 °C
•Systolic blood pressure, 90 to 150 mmHg*
•Diastolic blood pressure, 60 to 90 mmHg*
•Pulse rate, 50 to 90 beats per minute*.
•*Blood pressure and pulse rate will be taken again in a standing position. After two minutes standing, there shall be no more than a 20 mmHg drop in systolic or 10 mmHg drop in diastolic blood pressure, associated with clinical manifestation of postural hypotension).

排除标准

•Blood donation within 90 days
•History of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastroenterology, endocrine, immunology, dermatologic, neurologic or psychiatric disorders
•Subjects with a history of alcohol, drug abuse, chronic cannabis use within 2 years of study
•Pregnant women
•Subjects who used any prescription or OTC medication in the past 14 days with the exception of paracetamol or ibuprofen.
•Sexually active males whose partner is of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP. Sexually active females of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP
•Pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
•Subjects who had postural drop of > 20 mmHg in systolic blood pressure at screening
•Patients with heart failure,
•Subjects with a history of psychotic state in the past or anxiety disorder,
•Subjects at age of less than 30 years with a history of psychiatric disease in a first-degree family member
•Subjects with a history of addiction or drug abuse