An open label, balanced, randomized, single dose, two treatment, two period, two sequence, crossover, bioequivalence study comparing Dapagliflozin tablets 10mg, manufactured by Sun Pharmaceutical Industries Limited, India with Forxiga (Dapagliflozin) film-coated tablets 10 mg, manufactured by AstraZeneca AB Gärtunavägen, SE-151 85 Södertälje Sweden, in healthy adult, human subjects under fasting condition
This research trial is looking at two types of dapagliflozin 10mg tablets. One is already available as Forxiga, and the other is a new version made by a different company. The main goal is to check if these two tablets are absorbed and act in the body in the same way when taken by healthy adult volunteers. This is called a 'bioequivalence study' and it's important to make sure that new, more affordable versions of medicines work just as well as the original. Participants will fast before taking the medicine, and blood tests will be used to compare how the drugs behave in their system.
At a glance
What is this study about?
This study is comparing two different versions of a medicine called dapagliflozin. One version is already known as Forxiga, and the other is a new, perhaps more affordable, version made by a different company. The main aim is to see if these two tablets work exactly the same way in your body. This is a very common and important type of study when new versions of medicines are being developed.
The study is trying to find out if the new dapagliflozin tablet gets into your bloodstream at the same speed and in the same amount as the original Forxiga tablet. Think of it like comparing two brands of a fizzy drink; they might look a bit different, but this study wants to make sure they taste and have the same effect. This step is crucial before a new version of a medicine can be widely used by people with conditions like diabetes.
It’s important that medicines have what’s called 'bioequivalence.' This simply means that if you take one tablet, it should do the same job as the other, even if they’re made by different companies. This study is testing this in healthy adult volunteers to get clear and reliable results without the added effects of a health condition. This way, patients and doctors can be confident that new versions of medicines will be just as effective.
Key takeaways
- Compares a new dapagliflozin tablet with an existing one.
- Aims to check if both tablets work the same way in the body.
- Involves healthy adult volunteers, aged 18 and over.
- Requires fasting and blood samples after taking the medicine.
- Helps ensure new versions of medicines are safe and effective.
Who may be eligible?
To be part of this study, you need to be a healthy adult, 18 years old or older. The study is open to both men and women.
Because this study is comparing how medicines behave in the body, it is only for people who are generally healthy. It's not suitable for people who currently have diabetes or other long-term health conditions, as these could affect how the medicine works.
There might be other specific health checks or criteria once you inquire, but the main idea is that participants should be in good general health.
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 long-term medical conditions?
- Are you able to follow study instructions, including fasting?
- Are you able to attend multiple study visits for blood tests?
What does participation involve?
If you decide to take part, you'll be given both versions of the dapagliflozin tablet at different times. This is done to compare how each one works in your body. You'll switch between the two several times, making sure both are tested fairly within you. Before taking the medicine, you'll need to fast, meaning you won't eat anything for a certain period. After taking each tablet, you'll have several blood samples taken over a set amount of time. These samples will help the researchers understand how the medicine is absorbed and cleared from your body. The total duration of your participation, including all visits and follow-ups, will be explained in full detail if you are interested.
Potential risks and benefits
Locations (1)
- —UnverifiedRomania
Common questions
What is dapagliflozin used for?
Dapagliflozin is typically used to help manage type 2 diabetes by lowering blood sugar levels.
Why do you test healthy people instead of people with diabetes?
Testing healthy people helps researchers clearly see how the medicine works in the body without other health conditions affecting the results.
Will I need to stay overnight?
The study design will determine if any overnight stays are needed. This information will be fully explained before you agree to participate.
Will I get paid for taking part?
Many clinical trials offer payment or reimbursement for your time and travel. This will be discussed with you before you join.
What does 'fasting condition' mean?
Fasting means you won't be able to eat or drink anything (except water) for a certain number of hours before you take the study medicine.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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