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 fasting condition.
This research is looking at two forms of a medicine called bupropion hydrochloride sustained-release tablets, each containing 150 mg. Bupropion is a treatment commonly prescribed for major depressive illness. The study aims to check if a new version of this medicine works in exactly the same way as an existing one in the body. This is known as a 'bioequivalence' study. They are testing this on healthy adult volunteers to make sure any new bupropion medicine would be just as safe and effective for patients who need it for depression. It involves taking a single dose of each medicine and observing how they are absorbed.
At a glance
What is this study about?
Imagine you have two different brands of the same common painkiller. Even though they both contain the same active ingredient, you might wonder if they work identically in your body. That's a bit like what this study is doing, but for a medicine called bupropion, which is used to treat major depressive illness.
This study specifically wants to see if two different versions of 150 mg bupropion sustained-release tablets deliver the medicine to your body in the same way and at the same rate. One version is new, and the other is already on the market. This type of research is called a 'bioequivalence study' – 'bio' meaning life or body, and 'equivalence' meaning equal. It's a standard and very important step when new medicines, especially 'generic' versions, are developed.
The main goal is to make sure that if a patient switches from one brand of bupropion to another, they can expect the same relief and treatment effect for their depression. By testing this in healthy adult volunteers, scientists can be confident that future patients will receive consistent and effective treatment, regardless of which approved version of the medicine they take.
Key takeaways
- This study compares two versions of bupropion, a medicine for depression.
- It aims to confirm both versions work the same way in the body.
- Only healthy adults (18+) are eligible to participate.
- Participants will receive a single dose of each medicine on separate occasions.
- The study helps ensure medicines are consistently safe and effective.
- It is not a treatment for depression; it's a 'bioequivalence' study.
Who may be eligible?
This study is designed for healthy adults. To take part, you need to be at least 18 years old – there's no upper age limit for healthy participants. Both men and women are welcome to join.
The most important thing is that you are generally in good health. This means you shouldn't have any major ongoing medical conditions that could affect how your body handles the medicine or make it unsafe for you to participate.
- Are you 18 years old or older?
- Are you generally in good health?
- Are you comfortable having blood samples taken?
- Are you able to stay at a clinic for short periods?
- Do you understand this is not a treatment for depression?
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 visit a clinic for a short stay on two separate occasions. During each visit, you'll be given a single dose of one of the bupropion medicines being tested, but you won't know which one you're receiving (this is called 'double-blinded'). On one visit, you'll get the established medicine, and on the other, you'll get the new version. The order in which you get them will be decided randomly.
After taking the medicine, doctors and nurses will take blood samples regularly to see how your body absorbs and processes the drug. You'll be staying at the clinic during these periods to ensure accurate measurements and your safety. In between these two clinic visits, there will be a 'washout' period, meaning you won't take any study medication, to make sure one dose doesn't affect the next. The total time for your involvement, including all visits and the break in between, will be explained fully.
Potential risks and benefits
Locations (1)
- —Romania
Common questions
What is 'bupropion'?
Bupropion is a medicine often prescribed to help people with major depressive illness.
What does 'sustained-release' mean?
It means the medicine is released slowly into your body over time, so you don't have to take it as often.
Why are there two different versions of the same medicine?
Often, different companies make their own versions of an approved medicine. This study checks if they both work the same way.
Will I be given the medicine for depression treatment?
No, this study is to compare how the medicines are absorbed in healthy people, not to treat depression.
What is a 'healthy adult' in this study?
It means someone generally well, without major long-term health issues that would affect the study results or make participation unsafe.
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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