A Phase 1 relative bioavailability study in 14 healthy adult participants investigating the Arvisol® tablets to see whether its pharmacokinetic properties are similar to the reference drug which is a marketed oral soliton cannabidiol, named Epidiolex® CBD oral solution.
This research is a Phase 1 study, which means it’s one of the first human trials for a new tablet medicine called Arvisol®. The main goal is to compare how Arvisol® tablets are absorbed and used by the body to an existing, approved liquid medicine called Epidiolex®. Both medicines contain cannabidiol (CBD). By doing this, researchers want to see if the new tablet medicine acts in a very similar way to the liquid. This helps ensure that the tablet could be a reliable alternative in the future. We're looking for up to 14 healthy adult volunteers to take part, and it's important to understand that this is an early stage of testing new medications.
At a glance
What is this study about?
This study is an important first step for a new medication. Imagine you have a liquid medicine that works well, but sometimes it's easier to take a tablet. This study is trying to work out if a new tablet version of a medicine containing CBD (cannabidiol) works in exactly the same way as an existing liquid version which is already on the market.
The new tablet medicine is called Arvisol®, and the existing liquid medicine is Epidiolex®. The researchers want to carefully compare how much of the medicine gets into your bloodstream and how quickly your body uses it, for both the new tablet and the existing liquid. This comparison is called a 'bioequivalence' study.
Basically, if the new tablet behaves almost identically to the liquid in your body, it means it could be just as effective and safe. This kind of research is vital because it helps bring new, potentially more convenient, forms of medicines to patients. It's a key part of how new medications are developed and approved, slowly and carefully, to ensure they are beneficial and safe for people to use.
Key takeaways
- This study compares a new CBD tablet (Arvisol®) to an existing CBD liquid (Epidiolex®).
- It's a Phase 1 study, focusing on how the body uses the medicine.
- Only healthy adults aged 18 and over can join.
- The goal is to see if the tablet works similarly to the liquid.
- Participation involves taking doses and providing blood samples.
- You'll be closely monitored by medical staff.
Who may be eligible?
This study is looking for healthy adult volunteers. To take part, you need to be at least 18 years old – there's no upper age limit, as long as you are generally healthy.
Being 'healthy' means you don't have any major ongoing medical conditions, and you're not taking any medications that might interfere with the study drugs. The research team will do medical checks to make sure everyone who joins is suitable and to ensure their safety throughout the study.
Both men and women are welcome to take part in this study. The team will carefully explain all the requirements and check your health to make sure this study is right for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you generally healthy, without significant ongoing medical conditions?
- Are you able to visit the study clinic for appointments?
- Are you willing to have blood samples taken?
- Are you not currently taking any medications that might interfere with the study?
What does participation involve?
If you decide to take part, you'll be one of up to 14 healthy adult volunteers. The study involves taking doses of both the new Arvisol® tablet and the existing Epidiolex® liquid medicine, likely on separate occasions. This allows the researchers to compare how your body handles each one.
Throughout the study, you would likely spend time at a clinic where your health would be monitored. This would involve giving blood samples at different times after taking the medicine to measure how much of the drug is in your system. There might also be other health checks, like blood pressure and heart rate measurements.
The exact number of visits, how long each visit lasts, and the total duration of your participation would be fully explained by the research team. You would also receive detailed instructions about when and how to take the study medicines.
Potential risks and benefits
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Common questions
What is Epidiolex®?
Epidiolex® is a liquid medicine that contains cannabidiol (CBD) and is already approved for use in certain conditions.
What is Arvisol®?
Arvisol® is a new tablet form of a medicine that also contains cannabidiol (CBD). This study is comparing it to Epidiolex®.
What does a 'Phase 1' study mean?
Phase 1 studies are the first time a new medicine is tested in people. They are mainly to check safety and how the body handles the medicine.
Will I get 'high' from the CBD?
The CBD used in these medicines is purified and does not cause the 'high' associated with recreational cannabis.
How many people are in this study?
This is a small study, involving up to 14 healthy adult volunteers.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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