Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Randomised, crossover bioequivalence clinical trial of pregabalin 300 mg tablets versus pregabalin 300 mg hard capsules, after a single oral dose administration to healthy volunteers under fasting conditions.

This research study is looking at two types of pregabalin 300mg: a tablet and a hard capsule. Pregabalin is a medicine often used for nerve pain or epilepsy. The main goal is to check if these two forms of the medicine are absorbed by the body in a very similar way when taken by healthy adults. This is called 'bioequivalence'. If they are found to be very similar, it means they should have the same effects. This kind of study helps ensure that different versions of a medicine are just as effective and safe as each other. Participants will take a single dose of each form on different days, under fasting conditions, and researchers will measure how much medicine gets into their bloodstream and how quickly.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Normon S.A.

Enrolment target

Start

19 Sep 2022

Healthy volunteers

What is this study about?

Imagine you have a prescription for a medicine, and one day you get a tablet, and another day you get a capsule, but both say they contain the same amount of the drug. You'd want to be sure they work in exactly the same way, right? That's what this study is all about for a medicine called pregabalin.

Pregabalin is often prescribed for conditions like nerve pain or certain types of seizures. This study is testing pregabalin in a 300mg tablet form against a 300mg hard capsule form. The main aim is to see if your body absorbs these two forms in a very similar way. This is called a 'bioequivalence' study. It's really important because it helps ensure that if different companies make the same medicine, or if the same company offers it in different forms, they all deliver the same amount of the drug to your body at the same speed. This means you can be confident that the effect of the medicine will be the same, no matter which form you take.

To figure this out, healthy adult volunteers will take a single dose of the tablet on one occasion and a single dose of the capsule on another occasion, with some time in between. Researchers will then take blood samples to measure how quickly the medicine gets into the bloodstream and how much of it gets there overall. This tells them how well each form is absorbed. This type of research is a standard and necessary step in checking the quality and consistency of medicines available to us.

Key takeaways

The study compares two forms of pregabalin: a tablet and a capsule.
It aims to ensure both forms are absorbed similarly by the body (bioequivalence).
Healthy adults aged 18 and over can participate.
Participants will fast and take single doses of each form on separate occasions.
The findings help guarantee medicine quality and consistency.
It's a foundational study, not a treatment trial for a specific condition.

Who may be eligible?

This study is looking for healthy adults. You need to be at least 18 years old to take part. There isn't an upper age limit mentioned, so older adults who are otherwise healthy might also be able to join. Both men and women are welcome to participate.

To be considered 'healthy' for this study, it usually means you don't have any significant ongoing health problems, aren't taking regular medications (especially ones that could affect the study drugs), and are generally in good physical and mental health. The research team will do medical checks to make sure you fit their definition of healthy.

They will provide more specific details about other factors that might make you unsuitable, such as certain medical conditions, allergies, or if you've recently taken part in another clinical trial. It's important to discuss your full health history with the study team.

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?
Do you consider yourself generally healthy?
Do you not have any major ongoing health conditions?
Are you able to follow specific instructions about food and drink (like fasting)?
Are you willing to have regular blood tests?
Are you comfortable potentially staying at a clinic for short periods?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit where doctors will check your health to make sure it's safe for you to join. This usually involves a physical exam, blood tests, and reviewing your medical history.

Once you're approved, you'll take part in two separate study periods. In each period, you'll take a single dose of one of the pregabalin forms (either the tablet or the capsule) on an empty stomach. You'll stay at the study centre for a certain time after taking the dose, usually overnight or for several hours, so the research team can take regular blood samples. These samples will help them measure how the medicine moves through your body. There will be a 'washout' period between these two study periods, which means you won't take any study medication, to make sure the first dose is completely out of your system before you take the second.

The total time you are involved with the study, including screening, the two dosing periods, and any follow-up, will be explained fully by the study team. You'll need to follow specific instructions about food, drink, and other medications around the dosing times.

Potential risks and benefits

Taking part in this study could offer some benefits, such as contributing to medical knowledge and ensuring medicines are effective and safe for everyone. You might also receive some payment for your time and inconvenience. However, there are potential risks, including mild side effects from pregabalin (like dizziness or drowsiness), discomfort from blood draws, and the time commitment required. All procedures will be explained, and your safety will be closely monitored. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

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 pregabalin used for?

Pregabalin is a medicine often prescribed for nerve pain, certain types of seizures, and sometimes for anxiety disorders.

Why is this study only for 'healthy volunteers'?

Studies like this use healthy volunteers to understand how the medicine works in a typical body without other health conditions or medications complicating the results. This helps establish a clear baseline.

What does 'fasting conditions' mean?

It means you won't be allowed to eat or drink anything (except water) for a specified number of hours before and after taking the study medication. This is to ensure food doesn't affect how the medicine is absorbed.

What is 'bioequivalence'?

Bioequivalence means that two different versions of a medicine (like a tablet and a capsule) deliver the same amount of the active drug to the body at the same speed, meaning they should work in essentially the same way.

Will I receive treatment for any condition?

No, this is not a treatment study. You will not receive any medical treatment for a condition, as it's specifically for healthy volunteers to test how the body handles the medicine.