An open label, balanced, randomized, single dose, two treatment, two period, two sequence, crossover, bioequivalence study comparing Ivacaftor film coated tablets 150 mg of Sun Pharmaceutical Industries Ltd, India with Kalydeco (Ivacaftor) 150 mg film-coated tablets, Marketing Authorisation Holder: Vertex Pharmaceuticals (Ireland) Limited Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland, in healthy adult, human subjects under fed condition.
This study, called a bioequivalence study, is comparing two types of Ivacaftor 150 mg tablets. One is a new version made by Sun Pharmaceutical Industries, and the other is the existing Kalydeco medicine from Vertex Pharmaceuticals. Researchers want to see if the new medicine acts in the body in the same way as Kalydeco. This means checking if it's absorbed at the same rate and to the same extent. This type of study is done in healthy adults, not people with cystic fibrosis, and it's a very early stage of research. Participants will take both medicines at different times, and their health will be monitored. The main goal is to ensure that if the new medicine becomes available, it will have the same effects as the current one.
At a glance
What is this study about?
This study is looking at an existing medicine called Ivacaftor, which is used to treat cystic fibrosis. However, this study isn't actually testing the medicine in people with cystic fibrosis. Instead, it's comparing two different versions of the Ivacaftor 150 mg tablet in healthy volunteers. Think of it like comparing two different brands of a common painkiller – they both contain the same active ingredient, but this study checks if your body uses them in exactly the same way.
The main goal is to see if a newer version of the medicine, made by Sun Pharmaceutical Industries, is 'bioequivalent' to the original Kalydeco medicine. This simply means checking if your body absorbs it into the bloodstream at the same speed and level. If two medicines are bioequivalent, it means they are expected to have the same effects and safety when used by patients.
This kind of research is a very early step in drug development, known as a Phase I study. If the new Ivacaftor is found to be bioequivalent, it means it could potentially be used as another option for people with cystic fibrosis in the future, offering the same benefits as the original drug.
Key takeaways
- Compares two versions of Ivacaftor, an existing medicine for cystic fibrosis.
- A bioequivalence study checks if medicines are used by the body in the same way.
- Involves healthy adults, not people with cystic fibrosis.
- Early stage research (Phase I) to gather safety and absorption information.
- Participants take both medicines at different times, with careful monitoring.
Who may be eligible?
To join this study, participants need to be healthy adults, meaning they generally don't have any major ongoing health problems. The study is open to anyone aged 18 years and older, with no upper age limit specified.
Both men and women are welcome to take part in this research. The study needs people who are well and can follow the study instructions carefully. Specific health checks will be done before anyone is allowed to join to make sure it's safe for them.
While anyone over 18 can volunteer, the research team will do medical tests to confirm you are in good health. This is to ensure your safety and that the results of the study are clear and unaffected by other health issues.
- Are you 18 years old or older?
- Are you generally in good health?
- Are you willing to eat meals with the study medicine?
- Are you able to attend clinic visits regularly?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you will be given both the new Ivacaftor medicine and the existing Kalydeco medicine at different times during the study. This is called a 'crossover' study, meaning everyone gets both treatments. You'll take these medicines with food, and your health will be carefully watched.
The study involves several visits to a clinic over a period of time. During these visits, blood samples will be taken regularly to measure how much of the medicine is in your body. You'll also have health checks, such as blood pressure and heart rate measurements. There will be at least two separate periods where you take one of the medicines, with a 'washout' period in between where you don't take any study medicine to allow it to leave your system.
The total duration of your involvement will include screening checks to make sure you're eligible, the periods where you take the medicine and have measurements taken, and follow-up checks afterwards. The exact number of visits and the full length of the study will be explained in detail by the research team.
Potential risks and benefits
Locations (1)
- —Romania
Common questions
What is Ivacaftor used for?
Ivacaftor is a medicine used to treat genetic conditions like cystic fibrosis, but this study is comparing different versions of it in healthy people, not people with these conditions.
Will this study cure cystic fibrosis?
No, this study is not designed to cure cystic fibrosis. It is looking at how a new version of an existing medicine is processed by the body in healthy volunteers.
Why are healthy people needed for this study?
Healthy volunteers help researchers understand how a medicine works in the body without other health conditions making the results unclear.
Will I know which medicine I am taking?
This is an 'open label' study, which means both you and the study team will know which medicine you are taking at any given time.
Do I have to pay to join the study?
No, you will not have to pay to join the study. Any study medicines and procedures will be provided by the research team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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