ACTRN12622000961741已完成1 期
Phase I, open label, randomised three-way cross over study to determine the safety and pharmacokinetics of CBD administered as a single oral dose to healthy volunteers
Bod Limited0 个研究点目标入组 15 人开始时间: 2022年7月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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 30 Years（—）
- 性别
- All
入选标准
- •Male and females 18 – 30 years old
- •BMI 18.5-30 kg/m2
- •Otherwise healthy
- •Able to provide informed consent
- •Agree not to significantly change current diet/exercise
- •Agree not to use over-the-counter drugs (except oral contraceptive pill) or other dietary supplements (including CBD) during the study period
排除标准
- •Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function Malignancy)*
- •Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years
- •Currently taking any prescription medication (other than for contraception e.g., oral contraceptive pill)
- •Active smokers and nicotine or drug use (drug test will be administered)
- •Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- •Allergic to any of the ingredients in active or placebo formula
- •Diagnosed with serious mood disorders (such as depression and bipolar disorder)
- •People suffering any neurological disorders such as MS
- •Pregnant or lactating woman
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- •Participants who have participated in any other clinical trial during the past 1 month
研究者
相似试验
已完成
不适用
A phase I, open-label, randomized, three-way cross-over study comparing bioavailability of two formulations and assessing the food effect on tablet formulation after PXL770 single oral dose in healthy subjectsNon-alcoholic steatohepatitisNL-OMON49206Poxel SA12
已完成
不适用
A phase I, open-label, randomized, three-way cross-over study to determine the relative bioavailability of an oral capsule formulation, given both in the fasted state and after a high fat meal, compared to an oral suspension of PSN821 in healthy male volunteers.Diabetes Type II10018424NL-OMON34811OSI Pharmaceuticals16
进行中（未招募）
不适用
AMulti-drug resistant tuberculosisMedDRA version: 14.1Level: PTClassification code 10044755Term: TuberculosisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-005492-13-NLJanssen infectious diseases BVBA
已完成
不适用
A Phase I, open-label, randomized, 3-way crossover study in 3 Panels of healthy, adult subjects to assess the relative bioavailability of TMC207 following single-dose administration of two pediatric formulations using a 100 mg tablet formulation as the reference, with and without food.10004018tuberculosisNL-OMON38686Janssen Infectious Diseases BVBA36
已完成
不适用
A Phase 1, Open-label, Randomized, 3-way Crossover Study to Assess the Pharmacokinetic Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Subjectscold virusRespiratory syncytial virus10024970NL-OMON48293Janssen-Cilag International NV16