Comparative Bioavailability of Empagliflozin 25 mg Film-Coated Tablets: A Single-Dose, Open-Label, Randomized, Two-Sequence, Two-Treatment, Two-Period Crossover Study in Healthy Subjects Under Fasting Conditions.
This study, called a bioequivalence study, looked at two different 25 mg empagliflozin tablets: a new version (film-coated) and an existing one (Jardiance). Its main goal was to see if these two tablets delivered the same amount of the drug into healthy volunteers' bodies, and at similar speeds, after taking just one dose on an empty stomach. This is important to make sure that a new version of a medicine will work in the same way as the original. Researchers also kept a close eye on any side effects to ensure the safety of both tablets. The study followed a 'crossover' design, meaning each participant received both tablets at different times.
At a glance
What is this study about?
Imagine you have a headache and take a painkiller. You expect it to work the same way every time, right? This study is similar. It's comparing two versions of a medicine called empagliflozin (25 mg film-coated tablets) to make sure they are exactly the same in how they act inside the body. One version is what is called a 'reference' drug (Jardiance), and the other is a new version being tested.
The main idea is to see if the new empagliflozin tablet gets into your bloodstream at the same speed and delivers the same amount of medication as the established Jardiance tablet. This is crucial because it helps regulators and doctors know that if a patient switches from one tablet to the other, they will still get the full, correct dose of the medicine for their condition.
This kind of study is very important for patient safety and confidence. If a new version of a medicine is shown to be 'bioequivalent' – meaning it behaves the same way in the body – it means doctors can prescribe it knowing it will have the same treatment effect. This study focuses on how the body handles the medicine (called human pharmacology), specifically looking at how much and how quickly the drug is absorbed.
Key takeaways
- This study compares two empagliflozin tablets to ensure they work the same way in the body.
- It's a 'bioequivalence' study, checking that the new tablet delivers the same amount of medicine as the existing one.
- Only healthy adult volunteers are included to get clear results.
- Participation involves taking both tablets at different times and having blood tests.
- The study helps ensure medicines are safe and effective for future patients.
Who may be eligible?
To be considered for this study, you would need to be an adult, aged 18 years or older. The study is open to both men and women.
Crucially, this particular study is looking for healthy volunteers. This means that if you have any ongoing medical conditions, you would likely not be able to take part. The researchers want to see how the medicine acts in a healthy body, without other health issues that might change the results.
More detailed checks would be done by the study team, but generally, if you are a healthy adult, you might be a suitable candidate.
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 ongoing medical conditions?
- Are you able to attend clinic visits as required?
- Are you comfortable with having blood samples taken?
- Are you able to follow study instructions, such as taking medication on an empty stomach?
What does participation involve?
If you decide to take part in this study, you would receive a single dose of one of the empagliflozin tablets on one occasion, and a single dose of the other tablet on a different occasion. This is called a 'crossover' design, so you would act as your own comparison. You would take the tablets on an empty stomach.
To see how your body handles the medicine, you would have blood samples taken regularly after each dose. These samples help the researchers measure how much of the drug is in your bloodstream and how long it stays there. You would also have your vital signs (like blood pressure and heart rate) checked, and some routine lab tests, to monitor your safety.
The study would involve at least two separate visits to the clinic for drug administration and follow-up, with a 'washout' period in between when you wouldn't take any study medication. The total time you would be involved in the study would depend on how long this washout period is and how many follow-up checks are needed after the second dose.
Potential risks and benefits
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Common questions
What is empagliflozin used for in medicine?
Empagliflozin is a medicine typically used to treat Type 2 diabetes, and sometimes other heart and kidney conditions, to help lower blood sugar.
Why is this study only for healthy people?
Studies like this are done in healthy people first to understand how the drug works in the body without other health conditions affecting the results. This helps ensure the basic safety and absorption are understood.
What does 'bioequivalence' mean?
Bioequivalence means that two different versions of the same medicine act in the same way in the body – they deliver the same amount of drug at the same rate.
Will I get paid for taking part?
Clinical trials often offer some payment or reimbursement for your time and travel, but this would need to be confirmed directly with the study team.
What is a 'crossover' study?
In a crossover study, each participant takes both study treatments at different times, often with a break in between. This helps to compare the treatments within the same person.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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