Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A Randomized, Single-dose, Crossover, Two-period, Pilot Comparative Bioavailability Study of Alendronate 70 mg effervescent vs. Fosamax 70 mg tablets in Healthy Male and Female Subjects.

This study is looking at a new version of a medicine used to treat weak bones, called Alendronate. Instead of a regular tablet, this new version is a fizzy (effervescent) tablet. Researchers want to see if this new fizzy tablet gets into the body in the same way and at the same amount as the well-known tablet called Fosamax. This type of study is for healthy adult men and women, not people with a specific illness. It's an important step in developing new medicines, as it helps make sure that different forms of a drug work just as effectively and safely. You would switch between taking each type of tablet during the study.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Oractive Swiss AG

Enrolment target

Start

02 Aug 2024

not applicable (submitted trial is a comparative bioavailability study)

What is this study about?

Imagine you have a headache and you take a painkiller. You trust that the medicine will work, right? But what if that medicine came in a new form, like a fizzy drink instead of a pill? This study is similar. There's a medicine called Alendronate, which is used to help strengthen bones, often prescribed for conditions like osteoporosis where bones become weak and break easily. This medicine usually comes as a tablet.

Now, scientists have developed a new version of Alendronate that's an effervescent tablet, meaning it fizzes when you put it in water, like a soluble vitamin tablet. This study wants to find out if this fizzy Alendronate tablet works in exactly the same way in the body as a well-known tablet version called Fosamax, which also contains Alendronate. This is called a 'bioavailability' study – it's about how much of the medicine gets into your bloodstream and how quickly.

Why does this matter? If the new fizzy tablet gets into your body in the same way as the standard tablet, it means it should have the same effect. This is crucial for ensuring that a new version of a medicine is just as safe and effective as the one we already know. It helps doctors and patients feel confident that they’re getting the right treatment, no matter which form of the medicine they use.

Key takeaways

This study compares a new fizzy Alendronate tablet with an existing tablet called Fosamax.
It checks if both versions work the same way in the body.
The study is for healthy adults, both men and women, aged 18 and over.
Participation involves taking single doses of each medicine and having blood tests.
It helps ensure new medicine forms are safe and effective.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for healthy adults. This means you shouldn't have any serious health problems that could affect how your body handles medicines. Both men and women are welcome to take part.

You need to be at least 18 years old to join this study. There isn't an upper age limit, as long as you are generally healthy enough to participate.

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, without any major ongoing medical conditions?
Are you willing and able to visit a clinic for study appointments?
Are you comfortable with having blood samples taken regularly?
Are you willing to follow specific instructions about food and drink during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive both the new fizzy Alendronate tablet and the standard Fosamax tablet at different times. This is done to compare how your body reacts to each. You would likely visit a clinic for several days, possibly needing to stay overnight for some parts. During these visits, blood samples would be taken regularly to measure how much of the medicine is in your system. You would also have simple health checks like blood pressure and heart rate measurements. The total length of your participation, including all visits and follow-up, would be fully explained by the study team.

Potential risks and benefits

Participating in this study might offer the benefit of contributing to medical science and helping new medicine forms become available. However, there are potential risks, such as discomfort from blood draws, temporary side effects from the medicine (though you are healthy, medicines can still have effects), or inconvenience from clinic visits. You will be closely monitored by medical staff for your safety. Importantly, 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 does 'bioavailability' mean?

It means how much of the medicine actually gets into your bloodstream and becomes available to do its job in your body.

Will I be given the medicine for a long time?

No, this is a 'single-dose' study, meaning you'll only receive one dose of each medicine at different times, not regular daily doses.

Do I need to have a bone condition to join?

No, this study is actually for healthy adults, not people with specific bone conditions like osteoporosis.

What is a 'crossover' study?

It means that you will take both the fizzy tablet and the standard tablet at different times, allowing researchers to compare them in the same person.

Will I know which medicine I'm getting?

Often in such studies, for comparison, participants might not know which drug they are receiving at a particular time (this is called 'blinding'). The study team will explain how it works.