An open label, balanced, randomized, three treatment, three period, three sequence, single dose, crossover study to assess the effect of food and effect of apple sauce on bioavailability of the Test product (Bupropion Hydrochloride Extended Release Capsules 150 mg, manufactured by Sun Pharmaceutical Industries Limited, India) in healthy, adult, human subjects.
This research study is investigating an existing medicine called Bupropion Hydrochloride Extended Release Capsules, 150 mg. This medicine is used to treat conditions like Major Depressive Disorder and Seasonal Affective Disorder. The main goal of this study is to understand how the body absorbs this medicine differently when it's taken: 1) on an empty stomach, 2) with a meal, or 3) with applesauce. By finding out the best way for the body to absorb the medicine, doctors can better advise patients on how to take it to get the most benefit. Healthy adults over 18 can take part in this short-term study.
At a glance
What is this study about?
This study is about a medicine called Bupropion (you might know it by brand names like Wellbutrin). It's an antidepressant that helps people who have conditions such as Major Depressive Disorder or Seasonal Affective Disorder, which can affect mood and energy levels. The specific version of Bupropion being studied here is an 'extended release' capsule, meaning the medicine is released slowly into your body over time.
The main purpose of this research is to see how food affects the way your body takes in and uses this particular Bupropion capsule. We want to know if taking it with food, without food, or with applesauce changes how much medicine gets into your bloodstream and how quickly. This information is really important because it helps doctors and pharmacists give the best advice on how to take the medicine. If it's absorbed better in a certain way, it could work more effectively for patients.
This type of study is called a 'human pharmacology' study, or Phase I. This means it's one of the first steps in understanding a medicine. Researchers are carefully looking at how the body handles the medicine in healthy volunteers, rather than testing if it treats a specific illness. This helps ensure that the medicine is used in the safest and most effective way for future patients.
Key takeaways
- It's a study for healthy adults.
- Investigates an antidepressant medicine called Bupropion.
- Looks at how food (or applesauce) affects medicine absorption.
- Helps doctors give better advice on how to take the medicine.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for volunteers who are healthy adults. To take part, you need to be at least 18 years old – there is no upper age limit, as long as you are healthy enough to participate.
Since the study focuses on how a medicine is absorbed, it's really important that participants are generally in good health. This means you shouldn't have any major ongoing health conditions that could affect how your body processes medicines. The healthcare team will check your health carefully to make sure it's safe for you to join.
Men and women are both welcome to take part in this research. The study needs a variety of healthy people to get a good understanding of how the medicine works.
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.
- Am I at least 18 years old?
- Am I generally in good health?
- Do I have any serious ongoing medical conditions?
- Am I able to take medicines as instructed?
- Am I comfortable with having blood samples taken?
What does participation involve?
If you decide to join this study, you'll be one of the healthy volunteers helping us understand this medicine better. The study involves several visits to a clinic. You'll be given the Bupropion capsule on three different occasions, each time under different conditions: once with food, once without food, and once with applesauce.
After taking the medicine each time, the research team will take blood samples over a set period. This is to measure how much of the medicine is in your bloodstream at different times. These measurements help us see how quickly it's absorbed and how long it stays in your body. There will also be health checks, which might include things like measuring your blood pressure and heart rate to make sure you're feeling well throughout the study. The total duration of your participation in the study, including all visits and follow-up, will be clearly explained by the study team.
Potential risks and benefits
Locations (1)
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Common questions
What is Bupropion used for?
Bupropion is an antidepressant medicine that helps treat conditions like Major Depressive Disorder (long-term sadness) and Seasonal Affective Disorder (feeling low during certain times of the year).
Why is this study giving the medicine with applesauce?
Sometimes people have difficulty swallowing capsules, and applesauce can make it easier. This study wants to see if taking the medicine with applesauce affects how the body absorbs it, similar to how food might.
Will I get 'cured' of anything by joining this study?
No, this study is for healthy volunteers to understand how the body handles the medicine, not to treat an illness. It's about gathering information for future patients.
How long will I need to be involved?
The study involves three separate times you'll take the medicine, with some time in between each. The full duration of your involvement will be clearly explained by the study team.
Will I have to stay in a clinic overnight?
The information provided doesn't specify overnight stays, but the research team will give you a detailed schedule of visits and procedures.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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