A pilot, open label, single dose, randomized, four-period, four-sequence, four-treatment crossover, comparative bioavailability study of UDCA PMCS 500 mg formulation 1 film-coated tablets (test 1 formulation), and UDCA PMCS 500 mg formulation 2 film-coated tablets (test 2 formulation), and UDCA PMCS 500 mg formulation 3 film-coated tablets (test 3 formulation), and reference formulation in healthy, male and female volunteers under fasting conditions.
This research is looking at different versions of a medicine called UDCA, which is used to help with gallstones. The study wants to find out if three new tablet designs deliver the medicine into the body in the same way as a standard version. This is called a 'bioequivalence' study. To do this, healthy adult volunteers will take each version of the medicine on different occasions. By comparing how the different tablets are absorbed, the researchers can ensure that any new versions are just as effective and safe as the original. This type of study is an early stage of testing new medicines.
At a glance
What is this study about?
This study is looking at a medicine called UDCA (Ursodeoxycholic Acid), which is often used to help with gallstones. Gallstones are like small stones that can form in your gallbladder and can sometimes cause pain or other problems. UDCA works by helping to reduce the amount of cholesterol in your bile, which is a fluid your body makes to help digest fats. By doing this, it can help stop gallstones from forming or even dissolve existing ones over time.
Researchers have created three new versions of the UDCA tablet. This study wants to compare these new tablets with an existing, well-known UDCA tablet. The main goal is to see if all these different versions deliver the active medicine into the body in the same way and at the same rate. This is super important because it makes sure that if any of these new tablets are used in the future, they will work just as effectively as the current medicine.
This kind of study is a basic, early-stage step in developing new medicines. It helps scientists understand how the body handles different formulations of a drug. It's often done in healthy volunteers to get clear information without other health conditions complicating the results. The findings from this study will help ensure that future UDCA medicines are reliable and effective for patients.
Key takeaways
- This study is testing new versions of a medicine for gallstones (UDCA).
- It aims to ensure new tablets work the same as existing ones.
- Healthy adult volunteers, both men and women, are needed.
- Participation involves taking different tablets on separate days.
- Blood samples will be taken to see how the medicine is absorbed.
- Your contribution helps ensure safe and effective future medicines.
Who may be eligible?
To join this study, you need to be a healthy adult, aged 18 years or older. Both men and women can take part.
Being 'healthy' means you generally don't have any major medical conditions that could affect how your body takes in and uses medicine. The researchers will probably do some checks, like blood tests, to make sure you are in good health before you start.
Because this study is about how your body absorbs the medicine, you will be asked to take the medicine on an empty stomach.
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 comfortable having regular blood samples taken?
- Are you able to fast (not eat) for certain periods?
- Can you commit to four separate study visits?
What does participation involve?
If you decide to take part, you will be given four different versions of the UDCA medicine. You will take each version on a different day, meaning you'll visit the study clinic four separate times. Each time, you'll take the medicine after not eating for a certain period (fasting).
After you take the medicine, the study team will take several blood samples over a set number of hours. This is to measure how much of the UDCA medicine is in your blood at different times. This helps them understand how your body absorbs each version of the tablet. You'll likely stay at the clinic for several hours during each visit for these blood tests. The total duration of your participation will involve these four separate treatment periods.
Potential risks and benefits
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Common questions
What are gallstones?
Gallstones are small, hard deposits that can form in your gallbladder, which is a small organ that stores bile, a fluid involved in digestion.
What does 'fasting conditions' mean?
It means you will need to stop eating and drinking (except water) for a certain number of hours before you take the medicine, usually overnight.
Will I get paid for taking part?
Payment for participation is often offered in these types of studies to cover your time and travel, but you would need to confirm this with the study team.
What is a 'bioequivalence' study?
It's a study that compares different versions of the same medicine to make sure they work in the same way in the body – delivering the same amount of medicine at the same speed.
Will I know my results?
Generally, individual results from these types of studies are not shared with participants, but you can always ask the study team about their policy.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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