Bioequivalence study of the oral suspension of netupitant/palonosetron combination product versus the hard capsules of netupitant/palonosetron combination product after a single dose administration to healthy male and female volunteers in an open-label, randomised, single centre, 2-treatment, 4-period, 2 sequence replicative design
This study is looking for healthy adults to help us understand how a new liquid medicine, called netupitant/palonosetron, works in the body compared to the capsule version. Both forms of the medicine are used to help prevent sickness and vomiting, often caused by treatments like chemotherapy. We want to check if the liquid form is absorbed and used by the body in the same way as the current capsule. This is important to make sure the liquid medicine will be just as effective and safe for patients who might find capsules difficult to swallow. Your participation would involve taking both forms of the medicine at different times and having some health checks.
At a glance
What is this study about?
This research study is about a medicine called netupitant/palonosetron, which is used to prevent nausea and vomiting, especially for people receiving chemotherapy. Currently, this medicine is available as a capsule. However, some people, like those who have trouble swallowing or young children, might find it hard to take capsules.
That's why scientists have developed a new liquid form of the medicine. Before this liquid medicine can be used more widely, we need to make sure it works in the body in the same way as the capsule. This study will compare the liquid and capsule versions to see if the body absorbs and processes them similarly. This type of study is called a 'bioequivalence' study, which simply means checking if two different forms of a medicine do the same job in your body.
The findings from this study are really important. If the liquid form is shown to be just as effective as the capsule, it could provide a much-needed alternative for many patients, making it easier for them to take their medication and manage their symptoms. This could improve the quality of life for people who need this anti-sickness treatment.
Key takeaways
- This study compares a new liquid medicine to an existing capsule.
- It aims to see if both forms work the same in the body.
- Healthy adult volunteers, male and female, are needed.
- Participation involves taking both forms of the medicine and having blood tests.
- Your contribution helps make medicine more accessible for patients.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for healthy adult volunteers. This means you should generally be in good health and not have any serious ongoing medical conditions.
You must be at least 18 years old to take part. There is no upper age limit, so adults of any age above 18 are welcome to apply.
Both men and women can participate in this study. We need a mix of participants to get a good understanding of how the medicine works.
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 generally healthy?
- Are you 18 years old or older?
- Do you have any serious ongoing medical conditions?
- Are you able to visit a study centre multiple times?
What does participation involve?
If you decide to take part, you'll be asked to visit the study centre multiple times. During these visits, you will receive either the liquid form or the capsule form of the netupitant/palonosetron medicine. You'll take each form on different occasions.
Study staff will perform various assessments, which will include blood tests to check how the medicine is being absorbed and processed by your body. You might also have other routine health checks such as measuring your blood pressure and heart rate. You will be closely monitored after taking the medicine.
This is a 'single centre' study, meaning all your visits will be at one location. The study is designed in a 'replicative' way, which means you might take the same medicine form more than once, but at different times, to ensure accurate results. The total duration of your participation, including all visits and follow-up, will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is 'bioequivalence'?
It means we're checking if two different forms of a medicine, like a liquid and a capsule, work the same way in your body.
Is this medicine new?
The medicine itself (netupitant/palonosetron) has been used before, but the liquid version is new and being compared to the existing capsule.
Will I get paid to take part?
Payment for participation or reimbursement for travel expenses is usually discussed by the study team, but is not specified here. Please ask the study team directly.
What kind of health checks will I have?
You'll have blood tests to see how the medicine is absorbed, and possibly other routine checks like blood pressure and heart rate.
Can I leave the study if I change my mind?
Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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