Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Randomised, crossover bioequivalence clinical trial of escitalopram 20 mg capsules versus escitalopram 20 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions

This research is looking at an antidepressant medication called escitalopram. There are two slightly different ways this medicine is made: as a capsule and as a film-coated tablet. The main goal of this study is to compare these two forms. We want to check if, when healthy people take a single dose of either medicine on an empty stomach, their bodies absorb and use the escitalopram in a very similar way. This kind of study is important because it helps ensure that if a doctor prescribes escitalopram, both the capsule and the tablet form will have the same effect.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Alter Farmacia S.A.

Enrolment target

Start

04 Mar 2025

Antidepressants

What is this study about?

This study is about a commonly used antidepressant medicine called escitalopram. When drug companies make a medicine, sometimes they create it in slightly different forms, like a capsule or a tablet. Even though they contain the same active ingredient, it's important to check that your body processes both forms in the same way.

That's where this study comes in. It's designed to compare escitalopram 20 mg capsules with escitalopram 20 mg film-coated tablets. We want to see if your body absorbs the medicine and if it reaches your bloodstream at the same rate and to the same amount, whether you take it as a capsule or a tablet. This is called a 'bioequivalence' study.

By doing this research, we're helping to make sure that patients can confidently take either the capsule or the tablet form of escitalopram, knowing they will work equally well. It's a standard and important step in ensuring high-quality medicines are available.

Key takeaways

This study compares two forms of the antidepressant escitalopram: capsules and tablets.
It aims to ensure both forms work the same way in the body.
Healthy adults (18+) are welcome to participate.
You'll take a single dose of each medicine (on separate days) on an empty stomach.
Participation involves clinic visits, blood tests, and health checks.
You'll be contributing to medical research for better medicines.

Who may be eligible?

This study is looking for healthy adults to take part. You must be at least 18 years old to be considered. There's no upper age limit mentioned, so older adults could also be eligible. Importantly, both men and women are welcome to participate.

Since this study is testing how medicine works in healthy people, you shouldn't have any major ongoing health conditions. This helps us see how the medicine behaves without other health issues affecting the results. More detailed health checks will be done before you can join.

Please remember that being 'eligible' doesn't automatically mean you'll be accepted. There will be specific health checks and tests to make sure the study is safe for you and that you meet all the requirements.

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 in good health?
Are you able to follow study instructions, including fasting?
Are you comfortable having regular blood tests?
Are you available for multiple clinic visits over a short period?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be asked to visit the study clinic multiple times. On each visit, you'll be given a single dose of either the escitalopram capsule or the escitalopram tablet. This will happen on an empty stomach. You'll likely stay at the clinic for several hours after taking the medicine so that the study team can take regular blood samples to measure how the medicine is absorbed by your body. You'll also have health checks like blood pressure and heart rate monitoring.

Because it's a 'crossover' study, you'll take both forms of the medicine, but on different study days, with a break in between. This helps compare the two medicines fairly within the same person. The total duration of your participation, including all visits and follow-ups, would be explained fully by the study team.

Potential risks and benefits

Participating in a study like this might not directly benefit your health, as it's designed to gather information about a medicine. However, you would be contributing to medical knowledge, which helps ensure medicines are safe and effective for everyone. Potential risks could include minor discomfort from blood draws, temporary side effects from the escitalopram (like feeling sick, dizziness, or headache), or allergic reactions, though serious side effects are rare when given a single dose to healthy people. 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 escitalopram used for normally?

Escitalopram is a medicine commonly prescribed to treat conditions like depression and anxiety.

Why do you need healthy volunteers?

We need healthy volunteers to see how the medicine works in a typical body, without other health conditions or medicines affecting the results, which helps us understand it better for all patients.

What does 'fasting conditions' mean?

It means you won't be allowed to eat or drink anything (except water) for a certain period before and after taking the study medicine, usually overnight and for a few hours afterwards.

What is a 'crossover' study design?

In a crossover study, each participant takes both medicines being compared, but at different times. This means we can compare the capsule and tablet in the same person, making the results very clear.

Will I know if I'm taking the capsule or the tablet?

Yes, it's likely you would know which form of the medicine you are taking on each study day, because they look different.