An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Naltrexone hydrochloride film-coated tablet, 50 mg, manufactured by Sun Pharmaceutical Industries Limited, India with NALTREXONE GH (naltrexone hydrochloride) film-coated tablets 50 mg, Product of Generic Health Pty Ltd Suite 2, Level 2 19-23 Prospect Street Box Hill, VIC, 3128, Australia, in healthy adult, human subjects under fasting condition.
This study is comparing two types of a medicine called naltrexone. Naltrexone is used to help people who have a problem with alcohol dependence. One version is made by Sun Pharmaceutical Industries Limited in India, and the other is NALTREXONE GH from Australia. The main goal is to check if these two versions behave the same way in the body when taken by healthy adults on an empty stomach. This kind of study, called a bioequivalence study, makes sure that if you switch from one version of the medicine to another, it will have the same effect. It's a very early safety and effectiveness check, ensuring new medicines are just as good as existing ones.
At a glance
What is this study about?
This research study is about a medicine called naltrexone. Naltrexone is a treatment that helps people who have alcohol dependence, meaning they have trouble controlling their drinking. There are different companies that make naltrexone, and this study wants to compare two specific versions. One version is made by a company in India, and the other by a company in Australia.
The main purpose of this study is to see if both these naltrexone medicines are "bioequivalent." This is a medical term that simply means, do they act the same way in your body? For example, do they get absorbed at the same rate, reach the same level in your bloodstream, and stay in your system for a similar amount of time? It's really important for medicines that are meant to be the same to actually behave identically inside the body.
By checking for bioequivalence, researchers can feel confident that if someone takes the naltrexone from India or the naltrexone from Australia, they will get the same help for their alcohol dependence. This study is an early step in testing medicines, focusing on how healthy people's bodies handle the drug rather than treating the condition itself.
Key takeaways
- This study compares two different manufacturers of naltrexone.
- It checks if both naltrexone medicines act the same way in the body.
- Healthy adult volunteers, aged 18 and over, are needed.
- The study involves taking single doses of medicine and having blood tests.
- You will not be treated for alcohol dependence in this study.
Who may be eligible?
This study is looking for healthy adult volunteers to take part. This means you should be generally well and not have any serious ongoing health problems.
Both men and women are welcome to participate. You must be at least 18 years old to join this study. There is no upper age limit mentioned, as long as you are considered generally healthy.
Since this is an early-stage study that compares how bodies handle the medicine, they will be looking for people who don't have alcohol dependence themselves, as the focus is on the medicine's behaviour, not its treatment effect in patients.
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 at least 18 years old?
- Are you generally healthy with no serious existing medical conditions?
- Are you able to go without food for a certain time before taking medicine?
- Are you comfortable having regular blood tests?
- Are you able to commit to several clinic visits over a few weeks?
What does participation involve?
If you decide to take part, you would receive a single dose of one of the naltrexone medicines, and then at a later time, a single dose of the other naltrexone medicine. This is called a 'crossover' study, meaning you try both.
Throughout the study, you would come to a clinic where your health would be checked (like blood tests and vital signs). Your body's response to the medicine will be carefully monitored. You would need to be fasting (not eating for a certain period) before taking the medicine, and then blood samples would be taken regularly for a specific amount of time afterwards to see how the medicine moves through your body.
The visits would likely involve spending several hours at the clinic on different days. The total duration of your involvement could be several weeks, including breaks between the different medicine doses and follow-up checks. You wouldn't be taking the medicine for a long period, just single doses.
Potential risks and benefits
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Common questions
What is naltrexone used for?
Naltrexone is a medicine used to help people with alcohol dependence.
What does 'bioequivalence' mean?
It means researchers are checking if two versions of the same medicine work exactly the same way in the body.
Do I need to have alcohol dependence to join?
No, this specific study is looking for healthy adult volunteers, not people with alcohol dependence.
Will I take the medicine for a long time?
No, you will only take single doses of the medicine on different study days.
Will I be paid to participate?
Payment for participation is common in these types of studies; you should ask the study team about this.
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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