A double blinded, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study comparing Bupropion Hydrochloride Sustained-Release Tablets 150 mg, manufactured for Sun Pharmaceutical Industries Limited, India with PrOdan Bupropion SR (Bupropion Hydrochloride Sustained-Release Tablets 150 mg), product of Odan Laboratories Ltd., 325 Stillview Avenue, Pointe Claire, Quebec, H9R 2Y6, in healthy adult, human subjects under fed condition.
This research is looking at two versions of a 150 mg bupropion tablet. One is made by Sun Pharmaceutical Industries Limited, India, and the other is called PrOdan Bupropion SR from Odan Laboratories Ltd. The main goal is to check if these two versions deliver the same amount of medication to the body at the same speed. This is important to make sure that different brands of the same medicine work equally well for patients. The study involves healthy adult volunteers who will take each tablet once, on separate occasions, with food, allowing researchers to compare how the body handles each version.
At a glance
What is this study about?
This study is comparing two different versions of a medicine called bupropion. Bupropion is often used to help people with conditions like major depressive illness. When a medicine is made by different companies, it's really important to make sure that each version works in the same way in your body. This is called 'bioequivalence'. Think of it like comparing two different brands of a common painkiller – you'd expect them both to relieve pain in a similar way.
The researchers want to see if the bupropion tablet made by Sun Pharmaceutical Industries Limited works just like the one called PrOdan Bupropion SR. They do this by giving a single dose of each tablet to volunteers at different times and then carefully measuring how much of the medicine gets into the body and how quickly. This helps ensure that if one brand is prescribed instead of another, patients will still get the same safe and effective treatment.
This kind of study focuses on understanding how the medicine behaves in the body, which is why it's called a 'Human Pharmacology (Phase I)' study. By showing these two tablets are 'bioequivalent', it means doctors can choose between them with confidence, knowing patients will receive consistent and reliable medicine for their health needs.
Key takeaways
- Compares two bupropion tablets to ensure they work the same.
- Aims to confirm consistency in medication for conditions like depression.
- Involves healthy adult volunteers, aged 18 and over, both men and women.
- Participants take each tablet once, with food, and have blood tests.
- This is a 'Phase I' study, focusing on how the medicine acts in the body.
- Your participation helps ensure safe and effective medicines for patients.
Who may be eligible?
This study is looking for healthy adults. You need to be at least 18 years old to take part, and there's no upper age limit mentioned.
Both men and women can join this study. The most important thing is that you are generally healthy, as confirmed by medical checks before you start.
More detailed health checks will be done to make sure it's safe for you to participate and that your health won't affect the study results. These checks might look at your medical history and ask about any medicines you currently take.
- Am I at least 18 years old?
- Am I generally healthy (not currently ill)?
- Am I able to commit to the study visits and procedures?
- Am I willing to take medication and have blood samples taken?
- Am I comfortable with not knowing which tablet I'm receiving at any time?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you'll be asked to take two different bupropion tablets, each on a separate day, with food. This is a 'crossover' study, meaning you'll take one tablet first, and then after a break, you'll take the other. Researchers will take blood samples at specific times after you take each tablet to measure how much medicine is in your body. You'll likely have a medical check-up at the beginning and possibly at the end. The total duration of your active participation, including the breaks between taking the medicines, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —Romania
Common questions
What is bupropion used for?
Bupropion is a medicine primarily used to treat major depressive illness, and sometimes to help people stop smoking.
What does 'bioequivalence' mean?
It means two different versions of a medicine are compared to make sure they deliver the same amount of active ingredient to your body at the same speed, ensuring they work equally well.
Do I have to have depression to join?
No, this study is actually looking for healthy adult volunteers. The purpose is to see how the medicine works in a typical, healthy body, not to treat depression in participants.
Will I know which tablet I'm taking?
No, this is a 'double-blinded' study, meaning neither you nor the study staff will know which of the two bupropion tablets you are taking at any given time. This helps ensure unbiased results.
How long will I be involved in the study?
The total time you'll be involved in the study, including visits and time between doses, will be fully explained by the study team. Each dosing period involves taking the tablet and having blood samples taken afterwards.
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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