ACTRN12623000944639进行中（未招募）1 期
An open label, randomised, single oral dose, three-period, cross-over trial to assess the pharmacokinetics of Cannabidiol Oil (100 mg/mL) (reference) in comparison with two Cannabidiol 100 mg capsules (Test Drug, Swiss Manufactured and Australian Manufactured) in fasted healthy males
The University of Newcastle, Australia0 个研究点目标入组 12 人开始时间: 2023年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- Male
入选标准
- •1. Healthy male participants aged between 18 and 40 years,
- •2. Ability to communicate adequately with the investigator or their representatives
- •3. Ability to understand and agreement to comply with the study requirements and assessments
- •4. Provision of written informed consent
- •5. Non-smokers, non-vaper
- •6. Negative alcohol breath test results
- •7. Body Mass Index ranged between 18.5-30 kg/m2
- •8. Normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 40 to 100 bpm
- •9. Laboratory results within normal range or clinically non-significant (FBC, glucose, urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium, calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein and urinalysis), drug addiction scanning in urine results is negative (amphetamine, benzodiazepine, cannabinoid, cocaine, opiate),
- •10. He and his female partner will use contraception during the study and at least 7 days after the study.
- •11. Willing to fast overnight from 9pm, three times, prior to each treatment
排除标准
- •1. Who are not suitable to any of inclusion criteria.
- •2. Participants suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator’s judgement,
- •3. Who have known allergy for cannabidiol and/or any other ingredients of the products
- •(excipients),
- •4. History of difficulty of swallowing.
- •5. Participants who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug.
- •6. Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal (and/or GI Surgery), renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria.
- •7. Use of any drug including over-the-counter (OTC) that may have an interaction with Cannabidiol within 2 weeks prior to each treatment
- •8. History of drug or alcohol abuse, defined as diagnosed substance abuse disorder.
- •9. Use of any Cannabis or other illicit drug in past month, confirmed by negative drug screen
- •10. Regular use of more than 2 units of alcohol per day or 10 units per week and/or positive
- •alcohol breath test results (Note: one unit of alcohol equals 250 mL beer, 125 mL wine or 25
- •mL spirits).
- •11. Participants who have taken any grapefruit or grapefruit juice during 7 days prior to drug
- •administration, during the study.
- •12. Participants who have given more than 400 mL blood within the last two months before the first treatment and participants who have participated in any drug research within the last two months before the first treatment.
- •13. Participants who have a relationship with the study team.
研究者
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