A single-dose, open-label, randomized, two-period, two-sequence, crossover pivotal bioequivalence study on Dapagliflozin 10 mg film-coated tablets (Polfa Tarchomin S.A., Poland) versus Froxiga 10 mg film-coated tablets (AstraZeneca AB, Sweden) in healthy volunteers under fasting conditions.
This study looks at a new version of a medicine called Dapagliflozin (made by Polfa Tarchomin S.A.) and compares it to the commonly used Froxiga (made by AstraZeneca AB). Dapagliflozin is used to help manage type 2 diabetes, chronic heart failure, and chronic kidney disease. The study wants to see if the new version of the medicine is absorbed by the body in the same way as Froxiga. This is called a 'bioequivalence' study. Healthy adult volunteers will take a single dose of each medicine on separate occasions while fasting. The aim is to make sure the new medicine will work just as well and be just as safe as the original.
At a glance
What is this study about?
This study, called a bioequivalence study, is looking at a new version of a medication called Dapagliflozin. You might know the original brand of this medicine as Froxiga. Dapagliflozin is an important medicine used to help people with several serious conditions: it helps manage type 2 diabetes when diet and exercise aren't enough, it's used for people with long-term heart failure who have symptoms, and it also treats chronic kidney disease.
The main goal is to check if this new version of Dapagliflozin acts in the same way in the body as Froxiga. Imagine two similar cars; this study is like checking if they both perform exactly the same way on the road. For medicines, this means seeing if the new medicine gets absorbed into the bloodstream and reaches the same levels as the existing one. If they are 'bioequivalent,' it means they are expected to work just as well and be just as safe.
The researchers will give a single dose of each medicine to healthy volunteers at different times and then measure how much of the medicine gets into their blood. This helps prove that the new version is a trustworthy alternative to the original. This kind of study is a very early step in bringing a new medicine to people, making sure it meets all the strict standards.
Key takeaways
- This study compares a new version of Dapagliflozin to the existing medicine, Froxiga.
- It aims to confirm both medicines are absorbed by the body in the same way (bioequivalent).
- Dapagliflozin treats type 2 diabetes, chronic heart failure, and chronic kidney disease.
- The study involves healthy adults aged 18 and over.
- Participants will receive a single dose of each medicine at separate times, under fasting conditions.
Who may be eligible?
This study is looking for healthy volunteers. To take part, you need to be an adult, aged at least 18 years old. There is no upper age limit, meaning older adults can also participate.
Both men and women are welcome to take part in this study. The most important thing is that you are generally healthy and don't have any serious medical conditions that might affect how your body handles the medication being tested. You won't be eligible if you are currently taking other medications that could interfere with the study drugs, or if you have any conditions specifically treated by Dapagliflozin (like diabetes, heart failure, or kidney disease), as this study is for healthy individuals.
The research team will carry out a thorough health check to make sure you are suitable and safe to participate.
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?
- Do you not have diabetes, heart failure, or kidney disease?
- Are you free from other serious medical conditions?
- Are you able to follow specific fasting instructions?
What does participation involve?
If you decide to take part in this study, you will visit the study clinic on several occasions. During each visit, you will receive a single dose of one of the study medicines (either the new Dapagliflozin or Froxiga).
Since this is a 'crossover' study, it means that at different times, you will receive both the new medicine and the existing medicine. This allows researchers to compare how your body reacts to each. Before you take the medicine, you will need to fast, meaning you won't be able to eat or drink anything (except water) for a certain number of hours. After taking the medicine, blood samples will be collected regularly for a set period to measure how the medicine is absorbed and cleared from your body. You will also have check-ups to monitor your general health throughout the study. The total duration of your participation, including all visits and follow-ups, will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is Dapagliflozin?
Dapagliflozin is a medicine used to treat type 2 diabetes, heart failure, and chronic kidney disease. It helps the body get rid of excess sugar and fluids.
What does 'bioequivalence' mean?
Bioequivalence means that a new version of a medicine works in the body in the same way as an existing, approved version. It's absorbed at the same rate and to the same extent.
Why is this study only for healthy volunteers?
This study uses healthy volunteers so researchers can see exactly how the medicine is absorbed and processed by the body without other health conditions affecting the results.
Will I get both medicines?
Yes, in this type of study, each participant will receive a single dose of both the new Dapagliflozin and the existing Froxiga, but on separate occasions.
Do I have to fast before taking the medicine?
Yes, you will need to fast (not eat or drink, except water) for a certain number of hours before taking the study medicine to ensure consistent results.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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