Single dose, open-label, laboratory blinded, randomized, 2-treatment, 2-period, 2-sequence, crossover, pivotal study to assess the comparative bioavailability of Test Product Dapagliflozin/metformin hydrochloride 5 mg/1000 mg film-coated tablets to Reference Product Xigduo 5 mg/1000 mg film-coated tablets in healthy adult male and female subjects under fed conditions.
This research study is about a new version of a medicine used to treat type 2 diabetes. We want to see how this new medicine (called 'Test Product Dapagliflozin/metformin') is absorbed by the body compared to a widely used medicine called Xigduo. Both medicines contain the same active ingredients. We are looking for healthy adult men and women, aged 18 and older, to take part. Volunteers will be given both medicines at different times, after eating. This kind of study helps ensure that new versions of important medicines work just as well as existing ones. Your participation could help improve future treatments for people with type 2 diabetes.
At a glance
What is this study about?
This study is a special kind of research designed to compare two versions of a diabetes medicine. One is a new version of a tablet called 'Test Product Dapagliflozin/metformin hydrochloride', and the other is an existing tablet called Xigduo. Both contain the same active ingredients, dapagliflozin and metformin, which are used to help manage type 2 diabetes.
The main goal is to see if the new version is absorbed by your body in a similar way to the existing one. This is very important because it helps scientists make sure that any new medications, even if they have the same ingredients, will work effectively and safely. Everyone involved in the study will take both medicines at different times, after they have eaten a meal, so we can directly compare their effects within the same person.
Studies like this, called 'bioavailability studies', are a standard and necessary step in developing new medicines. They help regulatory bodies, like the UK's Medicines and Healthcare products Regulatory Agency (MHRA), ensure that people can trust the medicines they take. By taking part, you’d be playing a valuable role in advancing medical science and potentially helping countless people with type 2 diabetes in the future.
Key takeaways
- This study compares a new diabetes medicine version to an existing one.
- It aims to see if the new version is absorbed by the body in the same way.
- Healthy adult men and women, aged 18 and over, are needed.
- Participants will take both medicines (at different times) after eating.
- Your involvement helps ensure new treatments are safe and effective.
- You will be closely monitored by medical staff throughout.
Who may be eligible?
To be able to take part in this study, you need to be a healthy adult aged 18 or older. Both men and women are welcome.
This study is specifically designed for healthy volunteers, meaning you shouldn't have any major ongoing health conditions that could affect how your body processes medication. The study will also be done when you've eaten a meal, as this can sometimes change how medicines are absorbed.
The research team will review your medical history and conduct some checks to make sure this study is safe and suitable for you. They will explain everything in detail if you are interested in participating.
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 ongoing medical conditions?
- Are you able to attend several clinic visits, potentially lasting a full day?
- Are you comfortable with regular blood sampling?
What does participation involve?
If you decide to take part, you will visit the study clinic multiple times. You will receive a single dose of one of the medicines, and then later, you will receive a single dose of the other medicine. This allows the researchers to compare how your body handles both.
On the days you take the medicine, you will need to fast for a certain period before and then eat a standardised meal just before taking the tablet. The medical team will then take blood samples at specific times over several hours to measure how much of the medicine is in your bloodstream. You might stay at the clinic for part of the day or even overnight during these testing periods. The total duration of your involvement, including all visits and follow-up, will be explained fully by the study team.
Potential risks and benefits
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Common questions
What is a 'bioavailability study'?
It's a study that checks how well and how quickly an active medicine ingredient is absorbed into your body.
Why do you need healthy people for this study?
Using healthy volunteers helps researchers understand how the medicine behaves in the body without other health conditions affecting the results.
Will I get the new medicine or the old one?
You will get both! You'll take one medicine at one time and the other at a different time, so researchers can compare them within you.
Do I have to do anything special before taking the medicine?
Yes, you will likely need to fast for a period and then eat a controlled meal just before taking the study medicine.
What does being 'fed' conditions mean?
It means you will take the medicine after having eaten a meal, as food can sometimes change how medicine is absorbed.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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