An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Clarithromycin tablets 500 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Clarithromycin 500 mg coated tablets Manufactured by: Sanofi Medley Pharmaceuticals Ltd. Brazilian Industry, in healthy adult, human subjects under fasting condition.
This research is looking at two types of clarithromycin 500mg tablets, a common antibiotic used for various infections. One is made by Sun Pharmaceutical Industries Limited, India, and the other by Sanofi Medley Pharmaceuticals Ltd., Brazil. The main goal is to check if these two versions of clarithromycin are 'bioequivalent'. This means ensuring that they deliver the same amount of medicine to your body at the same speed, even though they're made by different companies. This is important to guarantee they will have the same effect in treating infections. Healthy adults will take a single dose of each medicine on separate occasions, allowing researchers to compare how their bodies process them, all while they haven't eaten recently.
At a glance
What is this study about?
This study is comparing two different versions of a medicine called clarithromycin. Clarithromycin is an antibiotic, which means it's used to treat common infections caused by bacteria, like some chest infections or skin infections. Both versions are 500mg tablets. One is made by a company called Sun Pharmaceutical Industries Limited, and the other by Sanofi Medley Pharmaceuticals Ltd.
The main aim of this study is to see if these two versions of clarithromycin are the same in how they act in your body. Even if they have the same amount of active ingredient, different brands can sometimes be absorbed slightly differently. This type of study, called a 'bioequivalence' study, checks that both medicines get into your bloodstream in the same way and at the same rate. This is important because it ensures that both versions will have the same healing effect when used to treat an infection.
So, essentially, the study wants to confirm that if your doctor prescribes clarithromycin, any approved 500mg tablet you take will work just as well, regardless of which company made it. This helps ensure that patients always receive consistent and effective treatment for their infections.
Key takeaways
- Compares two different brands of clarithromycin 500mg.
- Checks if they work the same way in the body (bioequivalence).
- Involves healthy adults, aged 18 and over.
- Participants will take a single dose of each medicine at different times.
- Helps ensure consistent quality of antibiotic treatments.
Who may be eligible?
This study is looking for healthy adult volunteers. You need to be at least 18 years old to take part, and there's no upper age limit, meaning older adults can also participate as long as they are generally healthy.
Both men and women are welcome to join this study. The most important thing is that you are healthy, as this study isn’t testing a new treatment, but rather comparing how two existing medicines work within someone's body.
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 with having blood samples taken?
- Are you able to follow study instructions, including fasting for periods?
What does participation involve?
If you decide to take part, you'll visit the study clinic several times. During your first visit, you'll undergo some health checks to make sure you're healthy enough for the study. You will then be randomly assigned to take one of the clarithromycin tablets first. You'll take a single dose of the medicine after not eating for a certain period (fasting condition). Staff will take blood samples regularly over a set amount of time to see how the medicine moves through your body.
After a break, which allows the first dose of medicine to completely leave your system, you'll come back to the clinic. You'll then take a single dose of the *other* clarithromycin tablet, again under fasting conditions, and have blood samples taken. This means you will receive both medicines at different times. The total duration of your involvement, including all visits and follow-up, will be explained to you in detail by the study team.
Potential risks and benefits
Locations (1)
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Common questions
What is clarithromycin?
Clarithromycin is a common antibiotic medicine used to treat various bacterial infections in the body.
What does 'bioequivalence' mean?
It means two medicines are compared to make sure they deliver the same amount of medicine to your body at the same speed, so they work the same way.
Will I get both medicines?
Yes, in this study, each participant will take a single dose of each of the two different clarithromycin tablets at separate times.
Do I need to be ill to join?
No, this study is specifically looking for healthy adult volunteers, not people who currently have an infection.
Why is this study important?
It helps make sure that different versions of the same medicine are equally effective and safe for patients who need them for infections.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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