Open-label, randomized, two-treatment, two-period, two-sequence, cross-over, single dose, bioequivalence study comparing ISOPRINOSINE® FORTE 100 mg/mL Syrup to ISOPRINOSINE® 500 mg tablets in healthy male and female subjects under fasting conditions.
This research study is about comparing two different versions of a medicine called Isoprinosine: a syrup and tablets. We want to check if both forms deliver the medicine into your body at a similar rate and to a similar extent when you take them without having eaten recently. This is known as a 'bioequivalence study'. It's a common and important type of study to ensure that different versions of a medicine, or new forms of an existing medicine, work just as effectively as each other. This helps doctors and pharmacists know they are giving you the right amount of medicine, regardless of whether it's a tablet or a liquid. Healthy adult volunteers are needed for this research.
At a glance
What is this study about?
This study is looking at a medicine called Isoprinosine. There are different ways to take many medicines, such as a syrup or a tablet. This research aims to find out if your body absorbs and uses the Isoprinosine syrup in the same way it uses the Isoprinosine tablets. Both will be taken on an empty stomach to ensure fair comparison.
Think of it like this: if you have a spoonful of honey or a honey sweet, you want to make sure you get the same amount of honey goodness, even if they're in different forms. In the same way, this study checks that the syrup and tablets deliver the same amount of the active medicine into your bloodstream at a similar speed.
This kind of study is really important. It helps ensure that when doctors prescribe a medicine, they can be confident that whether you take it as a liquid or a solid, you'll get the correct and consistent amount of treatment. This helps keep medicines safe and effective for everyone.
Key takeaways
- Compares a syrup and tablet form of Isoprinosine.
- Checks if both forms are absorbed equally well by the body.
- For healthy adult men and women, aged 18 and over.
- Involves two short stays at a clinic after taking the medicine.
- Aims to ensure medicines work consistently for patients.
Who may be eligible?
To take part in this study, you need to be a healthy adult aged 18 or over. This study is open to both men and women.
Because this study is about how your body handles the medicine, it's important that you don't have any major ongoing health problems. The researchers will carry out checks to make sure you are in good general health before you can join.
More detailed checks will happen before you start, but generally, if you're an adult and feel well, you might be suitable.
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 able to follow study instructions carefully?
- Are you able to attend clinic visits as required?
- Are you willing to avoid certain foods or medicines for the study?
What does participation involve?
If you join this study, you'll be taking part in what's known as a 'cross-over' study. This typically means you'll receive the syrup on one occasion and the tablets on another, with a break in between. You'll switch roles, so everyone gets both types of the medicine at some point.
Before you start, you'll have a screening visit where doctors will check your health. If you're suitable, you'll have two separate study periods. In each period, you'll receive a single dose of either the syrup or the tablets after not eating overnight. You'll stay at the clinic for a short period afterwards, usually a day or so, for blood samples to be taken regularly. These samples help researchers see how the medicine moves through your body.
After each dosing period, there will be a 'washout' period, a break designed to make sure all the medicine from the first dose has left your body before you get the second dose. The total duration of your involvement, including all visits and breaks, will be explained fully by the study team.
Potential risks and benefits
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Common questions
What is 'bioequivalence'?
It means comparing two versions of a medicine to see if they both deliver the same amount of the drug into your body at the same speed. It makes sure different forms of a medicine work the same way.
Why is this study important if Isoprinosine is already available?
Studies like this ensure that new forms of an existing medicine, like a syrup instead of a tablet, are just as safe and effective as the original, giving patients more choice in how they take their medicine.
Will I get paid for taking part?
It's common for healthy volunteer studies to offer some payment for your time and inconvenience. The study team will provide full details about this.
Do I need to stop taking other medicines to join?
You will be given clear instructions on any medicines you need to stop or avoid before and during the study. It's very important to tell the study team about all medicines you take, including over-the-counter ones.
Will I know if I was given the syrup or the tablet?
This is an 'open-label' study, which means both you and the study team will know which form of the medicine you are receiving at any given time. However, you will receive both forms during the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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