An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover, bioavailability study comparing Bupropion Hydrochloride Extended Release Capsules 150 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with WELLBUTRIN XL (Bupropion hydrochloride) extended release tablets 300 mg, Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA. Manufactured by: Bausch Health Companies, Inc. Steinbach, MB R5G 1Z7, Canada, in healthy, adult, human subjects under fasting condition.
This research is looking at two types of a medicine called bupropion, which is used to treat depression, including seasonal affective disorder and major depressive disorder. We are comparing a new generic version of bupropion extended-release capsules (150 mg) with the established medicine, Wellbutrin XL (300 mg tablets). The main goal is to find out if the body uses these two medicines in the same way. This is called a 'bioequivalence' study. Healthy adult volunteers will take each medicine on different occasions, and we will measure how the medicine levels change in their body. This helps ensure that the generic version is just as effective and safe as the original.
At a glance
What is this study about?
Imagine you have a headache, and you take a paracetamol tablet. You want to know it will work to relieve your pain. It's the same idea with medicines for depression. This study is like a test to make sure different versions of the same medicine work in the same way after you take them.
The medicine in question is called bupropion, which is a common treatment for certain types of depression, such as seasonal affective disorder (often called 'winter depression') and major depressive disorder. There's a well-known version called Wellbutrin XL, and a new, generic version being made by a different company. This study aims to check if this new generic bupropion is 'bioequivalent' to Wellbutrin XL.
'Bioequivalent' simply means that the new medicine gets into your bloodstream at the same rate and to the same extent as the original medicine. If they are bioequivalent, it means the generic version should have the same effects and be just as safe as the original. This is an important step to make sure patients can access effective and affordable generic medicines.
Key takeaways
- This study compares two bupropion medicines for depression.
- It aims to confirm a new generic version works like Wellbutrin XL.
- Healthy adults will take both medicines at different times.
- The study measures how the medicine acts in your body.
- Results help ensure safe and effective generic drugs.
Who may be eligible?
This study is looking for healthy adults to take part. This means you should generally be in good health and not have any serious ongoing medical conditions.
You must be at least 18 years old to be considered for this study. There is no upper age limit, as long as you are healthy enough to participate.
Both men and women are welcome to take part in this study. The researchers will carry out checks to make sure you are suitable and that participating would be safe for you.
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 specific study instructions?
- Are you willing to fast before taking medicine?
- Are you comfortable with regular blood tests?
What does participation involve?
If you decide to take part, you will visit the study clinic on a few occasions. In this type of study, you’ll take each of the two different bupropion medicines at different times, with a break in between. This means you will act as your own comparison, which is a very effective way to see how your body reacts to each medicine.
On each study day when you take a medicine, you will need to fast (not eat) beforehand. You will have blood samples taken regularly over several hours after you take the medicine to see how it moves through your body. You might also have other simple checks like blood pressure and heart rate measurements. The total time you'd be involved in the study – from the first screening visit to your last follow-up – will be explained to you in detail.
Potential risks and benefits
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Common questions
What is bupropion used for?
Bupropion is a medicine primarily used to treat depression, including major depressive disorder and seasonal affective disorder.
What does 'extended release' mean?
Extended-release means the medicine is released slowly into your body over many hours, so you don't have to take it as often.
What is a 'generic' medicine?
A generic medicine contains the same active ingredient and works the same way as a brand-name medicine, but is usually less expensive.
Why do you need 'healthy' people for this study?
Using healthy people helps researchers clearly see how the medicine behaves in the body without other health conditions complicating the results.
Will I know which medicine I am taking?
This is an 'open label' study, which means you will know which specific medicine you are receiving at the time you take it.
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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