Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence clinical trial of dapagliflozin 10 mg tablets, after a single oral dose administration to healthy volunteers under fasting conditions.

This study is like a test to make sure a new version of a medicine called dapagliflozin is just as good, safe, and effective as the original one already used for diabetes. Even though the medicine is for diabetes, this study is looking for healthy volunteers, not people with diabetes, because it helps scientists understand how the medicine behaves in the body without other health conditions getting in the way. Participants will take a single dose of the medicine while fasting, and doctors will carefully measure how the medicine is absorbed and processed. This kind of study helps bring reliable and affordable medicines to people who need them.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Alter S.A.

Enrolment target

Start

23 Sep 2024

Diabetes

What is this study about?

Imagine you have a key, and a new company makes a copy of that key. This study is like checking if the new key copy works exactly the same way to open the lock as the original key. In this case, the 'key' is a medicine called dapagliflozin, which is used for people with diabetes. The study wants to see if a newly made version of this medicine behaves in the body in the exact same way as the already approved one.

This type of study is really important because it helps make sure that new, often more affordable, versions of medicines are just as safe and effective as the originals. It means that when you get a prescription for a medicine, you can be confident that it will work consistently, no matter which company made it.

To do this, healthy volunteers (people who don't have diabetes or other ongoing health problems) will take a single dose of the medicine. Doctors will then take blood samples over time to measure how much of the medicine is absorbed into the bloodstream, how long it stays there, and how the body handles it. This gives scientists vital information to confirm the new medicine acts just like the original.

Key takeaways

This study makes sure new versions of existing diabetes medicines work the same.
It uses healthy adult volunteers, not people with diabetes.
Participants will take a single dose of the medicine after fasting.
Blood samples will be taken to see how the medicine is absorbed.
Your participation helps bring new, reliable medicines to patients.
You can withdraw from the study at any time without consequences.

Who may be eligible?

To join this study, you need to be an adult, which means you must be 18 years old or older. There is no upper age limit, so older adults can also take part. Both men and women are welcome to participate.

Crucially, this study is looking for healthy volunteers. This means you shouldn't have any ongoing medical conditions, especially diabetes, or be taking regular medication for any health issues. The study needs to see how the medicine works in a healthy body without other health problems affecting the results.

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 and do not have any major ongoing medical conditions (like diabetes)?
Are you not currently taking any regular prescription medications?
Are you comfortable with blood tests?
Are you able to fast for a specified period of time?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to come to a special clinic. You will need to fast (not eat or drink anything except water) for a certain number of hours before you take the study medicine. You'll take a single dose of the dapagliflozin tablet.

After taking the medicine, you'll stay at the clinic for a period of time, usually for several hours or even a day, so that nurses and doctors can take regular blood samples. These samples help them measure how the medicine is absorbed into your body. You might also have a few basic health checks, like your blood pressure and heart rate, before and after taking the medicine. The total time you'd need to dedicate to the study would typically involve one or two visits with follow-up calls.

Potential risks and benefits

The main benefit of taking part is contributing to medical science, helping to ensure new medicines are safe and reliable for future patients. You might also be compensated for your time and travel. Potential risks are generally low in this type of study, but could include discomfort from blood draws (like bruising or feeling faint), and possible mild side effects from the medicine, though it's given as a single dose to healthy people. You will be closely monitored, and you are free to withdraw from the study at any time without giving a reason.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is dapagliflozin?

Dapagliflozin is a medicine typically used to help manage type 2 diabetes by helping the body remove more sugar through urine.

Why does this study use healthy volunteers?

Using healthy volunteers helps researchers understand exactly how the medicine is absorbed and processed in the body without other health conditions or medicines affecting the results.

Will I get paid for taking part?

Many studies like this offer financial compensation for your time, travel, and inconvenience. You should ask the study team about this.

How long will I need to be at the clinic?

You will likely need to spend several hours, possibly even a full day, at the clinic for observations and blood tests after taking the medicine.

What does 'fasting conditions' mean?

Fasting means you cannot eat or drink anything (except plain water) for a specific number of hours before you take the study medicine.