NL-OMON49009招募中不适用
A two part bioavailability study on synthetic THC containing chewing gum formulations in healthy male and female volunteers. - CS0325 Axim THC
Axim Biotechnologies B.V. .0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- Subject is willing to give written informed consent.
- •- Subject is a healthy male or female between 18 and 55 years of age,
- •inclusive, at Screening.
- •- A body mass index (BMI) in the range of >=18.0 kg/m2 and <=30.0 kg/m2 at
- •- Subject is in good health as judged by the Investigator and based on medical
- •history, physical examination, vital sign measurements, ECG, and laboratory
- •safety tests performed at Screening.
- •Please refer to the protocol for more inclusion criteria.
排除标准
- •- Women who are pregnant or nursing, or planning to do so soon.
- •- Subject is mentally or legally incapacitated, has significant emotional
- •problems at the time of Screening or is expected to get significant emotional
- •problems during the conduct of the study or has a history of clinically
- •significant psychiatric disorder within the last 5 years.
- •- Subject has a history of clinically significant endocrine, gastrointestinal,
- •cardiovascular, hematological, hepatic, immunological, renal, respiratory,
- •genitourinary or major neurological (including stroke and chronic seizures)
- •abnormalities or diseases. Subjects with a history of cholecystectomy,
- •uncomplicated kidney stones, as defined as spontaneous passage and no
- •recurrence in the last 5 years, or childhood asthma may be enrolled in the
- •study at the discretion of the investigator.
- •Please refer to the protocol for more exclusion criteria.
研究者
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