A randomized, open-label, single dose, cross-over bioavailability study evaluating the drug-drug interaction between Tritace 10, 10 mg, tablets and Tertensif SR 1.5 mg prolonged-release film-coated tablets when co-administered versus the administration of each product alone in two cohorts of healthy volunteers under fasting conditions. Sponsor's Study No.: RAM-IND-DDI-05-23
This research study, called RAM-IND-DDI-05-23, is investigating how two medicines, Tritace 10 (used for blood pressure) and Tertensif SR (also for blood pressure), interact with each other in the body. Healthy volunteers will take each medicine alone and then together to see if one medicine affects how the other is absorbed or processed. The main goal is to understand these interactions and also to check that the medicines are safe and well-tolerated when given in different ways. This is an early stage study, often called Phase 1, that helps doctors understand new information about existing medicines.
At a glance
What is this study about?
This study is about understanding how two commonly used medicines, Tritace 10 and Tertensif SR, work in your body. Both of these medicines are often prescribed to help manage blood pressure. Sometimes, people might need to take both medicines at the same time, or they might be taking one and then need to start the other. The main purpose of this study is to see if combining these two medicines changes how your body uses them compared to taking each medicine on its own. For example, does taking them together mean one medicine is absorbed more quickly or slowly?
Because we want to see how these medicines act without other health problems affecting the results, this study is being carried out with healthy volunteers. This helps researchers get a clear picture of how the drugs interact. By understanding these interactions, doctors can make more informed decisions when prescribing these medicines together, ensuring patients get the most benefit with the fewest side effects.
This kind of research is really important. It helps healthcare professionals understand the best ways to combine treatments for patients. It's an early step in drug development, even for medicines that are already available, to gather specific information about how they behave in different situations.
Key takeaways
- This study helps understand how two common blood pressure medicines, Tritace 10 and Tertensif SR, interact.
- It involves healthy volunteers and is an early stage (Phase 1) study.
- Participants will take the medicines alone and together over several visits.
- The main goal is to check for drug interactions and safety.
- Being part of the study means contributing to valuable medical knowledge.
Who may be eligible?
To join this study, everyone must be at least 18 years old. There's no upper age limit, meaning older adults can also take part. Both men and women are welcome to participate in this research.
Since this study is specifically looking at how medicines interact in healthy people, you would need to be in good general health to be considered. This means you shouldn't have any major ongoing health conditions that could affect how your body responds to the medicines.
During the screening process, the study team will ask you questions about your health and history and may do some checks to confirm you are healthy enough to participate safely.
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?
- Do you consider yourself generally healthy?
- Are you comfortable with taking study medicines?
- Are you comfortable with having blood samples taken?
- Could you commit to multiple study visits over a period of time?
What does participation involve?
If you decide to take part, you'll be one of 94 healthy volunteers. The study involves a 'cross-over' design, which means you'll receive the medicines in different orders at different times. You will likely visit the study clinic multiple times. During these visits, you'll take either Tritace 10, Tertensif SR, or both together. For each period, blood samples will be taken at specific times after you take the medicine. This is to measure how much of the medicine is in your body and how long it stays there. You'll be asked to fast before taking the medicine, meaning you can't eat for a certain period beforehand. There will also be health checks throughout to ensure your safety. The total duration of your involvement, including all visits and follow-ups, will be explained fully by the study team.
Potential risks and benefits
Locations (1)
- —UnverifiedCzechia
Common questions
What does 'drug-drug interaction' mean?
It means how one medicine might change the way another medicine works in your body when you take them at the same time.
Why is this study only for healthy people?
By studying healthy people, researchers can get a clearer picture of how the medicines interact without other health conditions making the results harder to understand.
Will I get both medicines at once, or separately?
You will take each medicine alone at different times, and also take them together, in a specific order designed by the researchers.
What does 'fasting conditions' mean?
It means you won't be able to eat or drink anything (except water) for a certain number of hours before taking the study medicine.
Is this a new medicine?
No, both Tritace 10 and Tertensif SR are existing medicines. This study is learning more about how they work together.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.