Randomised, crossover bioequivalence clinical trial of hydrochlorothiazide 25 mg tablets, after a single oral dose administration to healthy volunteers under fasting conditions.
This research is a 'bioequivalence' study. This means we are comparing two different 25mg hydrochlorothiazide tablets. Hydrochlorothiazide is a medicine often used to treat high blood pressure or reduce fluid retention. We want to see if a new tablet (Hidroclorotiazida Normon) works in exactly the same way as an existing one (Esidrex) when taken by healthy volunteers. Participants will take each tablet on different occasions, and we will measure how much of the medicine gets into their bloodstream and how quickly. This helps ensure that both versions of the tablet are equally safe and effective for patients.
At a glance
What is this study about?
This study is called a 'bioequivalence' study. This is a common and important type of research that helps make sure medicines work correctly. In simple terms, it means we're comparing two different versions of the same medicine to see if they act in the same way in the human body. Think of it like comparing two different brands of a common painkiller; you want to be sure both brands will give you the same relief.
The medicine being studied here is hydrochlorothiazide, in a 25mg tablet form. Hydrochlorothiazide is a well-known medicine often used to help lower high blood pressure or to reduce extra fluid in the body (a condition called oedema). In this study, we are looking at an existing tablet called Esidrex and comparing it to a new one called Hidroclorotiazida Normon. Our main aim is to check if the new tablet delivers the medicine to your body in the same amount and at the same speed as the existing one.
This kind of study matters because it helps ensure that when doctors prescribe a specific dose of a medicine, patients will always receive the intended effect, regardless of which branded or generic version of that medicine they receive. If the new tablet is found to be 'bioequivalent' to the established one, it means they are considered interchangeable, providing patients with more options for their treatment.
Key takeaways
- Compares two versions of hydrochlorothiazide 25mg tablets.
- Aims to confirm both tablets work the same way in the body.
- Involves healthy adult volunteers (aged 18+).
- Requires taking both tablets at different times and blood tests.
- Helps ensure medicine effectiveness and safety.
- Participation is voluntary and you can withdraw anytime.
Who may be eligible?
This study is looking for healthy adults to take part. To be eligible, you need to be at least 18 years old, and there is no upper age limit. Both men and women can participate in this research.
Because this is a study involving medicines, the research team will ask you questions about your health and may do some checks to make sure it's safe for you to take part. For example, they'll want to ensure you don't have any health conditions that could be affected by the study medicine, or that could affect how your body handles the medicine.
Specific details about your health and any other medicines you take will be discussed with you thoroughly by the study team before you decide whether to join.
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 at least 18 years old?
- Are you generally healthy and don't have any major ongoing medical conditions?
- Are you comfortable having regular blood samples taken?
- Are you able to follow specific instructions, like fasting before taking medicine?
What does participation involve?
If you decide to take part, you will be given a single 25mg dose of one of the hydrochlorothiazide tablets. At a later date, you will then be given a single 25mg dose of the other tablet. This is known as a 'crossover' study, meaning you will try both medicines at different times.
Throughout the study, you will need to come to a clinic for visits. During these visits, the study team will take blood samples at specific times to measure how much of the medicine is in your bloodstream. These measurements, such as how much medicine reaches your body overall (AUC0-t) and the highest level it reaches (Cmax), are key to understanding how the tablets work. You'll be asked to take the medicine while fasting, meaning you won't have eaten for a certain number of hours beforehand. The total duration of your involvement will depend on the schedule of these visits and the time between taking each tablet, but typically these kinds of studies involve a few visits over a period of days or weeks, with follow-up calls or checks as needed.
Potential risks and benefits
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Common questions
What is hydrochlorothiazide used for?
It's a medicine often used to treat high blood pressure or reduce fluid build-up in the body. It helps your kidneys get rid of extra salt and water.
Why are you comparing two different tablets?
We want to make sure that a new version of the tablet works exactly the same way in the body as an existing, approved one. This helps ensure both are equally effective.
Will I have to stay overnight in a clinic?
The information provided doesn't specify overnight stays, but it does mention you'll take the medicine under fasting conditions and have blood samples taken at various times. The study team will give you a detailed schedule.
What does 'healthy volunteers' mean?
It means the study is looking for people who generally don't have any major ongoing medical conditions or take regular medicines that could interfere with the study drug.
Do I have to pay to take part?
No, you will not have to pay to take part in this research. You may even be compensated for your time and travel.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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