An open label, randomized, single-dose, two-sequence, two-period, crossover comparative bioavailability study to assess the pharmacokinetic and safety profile of Dofetilide intravenous solution compared to Tikosyn® (Dofetilide) oral capsule in healthy subjects under fasting conditions.
This study is about a heart medication called dofetilide. Currently, dofetilide is taken as a capsule by mouth. Researchers are developing a new liquid form that can be given through a drip into a vein. This study wants to compare how quickly and effectively the body absorbs and uses both the new liquid form and the standard capsule. Healthy adult volunteers will take both forms at different times, so researchers can see if they work similarly and if both are safe. This type of early-stage research is important for understanding new ways to give medicines.
At a glance
What is this study about?
This study is an early-stage research project designed to understand how a specific heart medication, called dofetilide, behaves in your body. Dofetilide is used to help manage certain heart rhythm problems. Currently, people take dofetilide as a capsule by mouth.
The main goal of this study is to compare a new liquid form of dofetilide, which would be given directly into a vein (like a drip), with the existing capsule form. Researchers want to see if both forms of the medicine are absorbed and used by the body in a similar way. This is called a 'bioavailability' study, and it helps to ensure that any new way of giving a medicine works just as well as the original.
By carefully comparing these two forms in healthy volunteers, scientists can gather important information about how the new liquid version works. This kind of research is essential to make sure new treatments are safe and effective before they can be used more widely for patients who need them.
Key takeaways
- Tests a new liquid form of dofetilide compared to the capsule.
- Aims to understand how the body absorbs and uses the medicine.
- Involves healthy adult volunteers.
- You would receive both the liquid and capsule form at different times.
- Close medical monitoring during participation.
Who may be eligible?
This study is looking for healthy adults to take part. This means people who are generally well and don't have any serious ongoing health conditions.
You would need to be at least 18 years old to participate. There's no upper age limit, so adults of any age, as long as they are healthy, can be considered.
Both men and women are welcome to take part in this study.
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 with no major medical conditions?
- Are you comfortable with blood tests?
- Are you able to follow study instructions carefully?
What does participation involve?
If you take part, you'll be one of the healthy volunteers who will receive the medication. You will receive a single dose of the liquid dofetilide given into a vein and, at a different time, a single dose of the dofetilide capsule by mouth. This is a 'crossover' study, meaning everyone gets both versions, but in a different order.
Throughout the study, you'll have several visits to the research clinic. During these visits, the research team will take blood samples to measure how much dofetilide is in your body over time. They will also check your heart activity and general well-being to make sure you're safe. The exact number of visits and the total time you'd be involved aren't specified here, but typically these kinds of studies involve a few clinic visits or stays over a few weeks, with time between doses.
Potential risks and benefits
Locations (1)
- —UnverifiedBulgaria
Common questions
What is dofetilide used for?
Dofetilide is a medicine used to help people with certain types of irregular heart rhythms.
Why are you comparing a liquid and a capsule?
Researchers want to see if a new liquid form (given into a vein) works in the body similarly to the existing capsule form, and if it's safe.
Will I have to stay overnight?
The information provided doesn't specify, but studies where medicines are given into a vein often involve longer visits or overnight stays for monitoring.
Is this a new medicine?
No, dofetilide is an existing medicine. This study is testing a new way of giving it (as a liquid into a vein) compared to the standard capsule.
What does 'healthy subjects' mean?
It means people who don't have any significant health problems or illnesses that could affect how the medicine works or put them at higher risk.
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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