Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A randomised, open label, three periods, three-treatment crossover study to evaluate the pharmacokinetics of alendronic acid oral formulations after single dose administration in healthy volunteers under fasted conditions: a pilot study

This research is a small, early-stage study designed to understand how different versions of a medicine called alendronic acid work in the body. Alendronic acid is commonly used to treat conditions that weaken bones, like osteoporosis. We're asking healthy volunteers to take single doses of different alendronic acid formulations, without having eaten beforehand. The main goal is to measure how quickly and how much of the medicine gets into the bloodstream and how it leaves the body. This information helps scientists understand if different forms of the medicine are absorbed in the same way, which is important for developing effective treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Faes Farma S.A.

Enrolment target

Start

08 Sep 2025

Pharmacokinetic study in healthy volunteers under fasted conditions.

What is this study about?

This study is a type of research called a 'pharmacokinetic study.' In simple terms, 'pharmacokinetics' is the study of what the body does to a medicine – how it absorbs the drug, where it goes in the body, how the body changes it, and how it gets rid of it. For this particular study, researchers are focusing on alendronic acid, a medicine often prescribed to strengthen bones and treat conditions like osteoporosis.

The main purpose is to compare a few different ways alendronic acid can be given. We want to see if the body handles these different forms in the same way. Healthy volunteers will be asked to take a single dose of each form of the medicine on separate occasions, always on an empty stomach. This helps the researchers get a clear picture of how each formulation is absorbed without food interfering.

This kind of early research, often called a Phase I study, is crucial. It helps pharmaceutical companies understand how new drug formulations work in people and decide whether they are promising enough to continue with larger studies. It's a foundational step to ensure that medicines are effective and safe for future patients. This study isn't about treating a disease, but about understanding the medicine itself.

Key takeaways

This study is about how a bone medicine travels through the body.
It uses healthy volunteers, not people with a disease.
Participants will take the medicine on an empty stomach.
Blood samples will be taken to measure medicine levels.
This research helps improve future medicines.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 years or older. This means you should generally be in good health and not have any ongoing serious medical conditions that might affect how your body handles the medicine.

Because this is a study about how the medicine is absorbed, you also need to be able to take the medicine on an empty stomach as instructed. Both men and women can take part in this research.

Specific checks will be done by the study team to make sure it's safe for you to participate and that you meet all the requirements for healthy volunteers.

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?
Do you not have any serious ongoing medical conditions?
Are you able to take medicine on an empty stomach?
Are you comfortable with regular blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be in the study for a short period, likely involving three separate visits over a few weeks or months. During each visit, you will receive one of the alendronic acid formulations to take, always on an empty stomach. You'll then have blood samples taken at regular times over several hours to measure how the medicine moves through your body. There will also be health checks, like measuring your blood pressure and heart rate, at the beginning and end of each visit. The total duration of your involvement will depend on the time needed between each of the three study periods (called 'crossover' periods), and the follow-up after the last dose.

Potential risks and benefits

The main benefit of participating is contributing to medical science and helping develop a better understanding of medicines for bone health. As with any medicine, there's always a small risk of side effects, even in healthy people. The study team will explain all known potential side effects of alendronic acid. 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
Czechia

Common questions

What is alendronic acid used for normally?

Alendronic acid is a medicine commonly used to strengthen bones and treat conditions like osteoporosis, which makes bones weak and brittle.

Why do I need to take the medicine on an empty stomach?

Taking the medicine on an empty stomach helps researchers see exactly how well the medicine is absorbed without food interfering, giving a clearer picture of its effects.

Will this study cure a disease?

No, this study is not designed to treat a disease. It's an early-stage study to understand how a medicine works in healthy people.

What is a 'healthy volunteer'?

A 'healthy volunteer' is someone generally in good health, without any significant medical conditions that might affect the study results or put them at undue risk.

Will I know which type of alendronic acid I am getting?

Yes, this is an 'open label' study, meaning both you and the study team will know which formulation of alendronic acid you are receiving at each visit.