An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Lamotrigine Dispersible Tablets BP 100 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Lamictal (Lamotrigine) Dispersible Tablets 100 mg, Manufactured by: Delpharm Poznaÿ – Poland & Registered and Imported by: GlaxoSmithKline Brasil Ltda, in healthy adult, human subjects under fasting condition.
This research is looking at two types of lamotrigine, a medication used to help people with epilepsy and bipolar disorder. One is a new tablet made by Sun Pharmaceutical Industries Limited, and the other is an existing tablet called Lamictal. The main goal is to find out if the new tablet works in the body in the same way as the established Lamictal. To do this, healthy adult volunteers will receive a single dose of each tablet at different times. This type of study, called a bioequivalence study, helps ensure that new versions of medicines are just as safe and effective as the original ones before they become widely available.
At a glance
What is this study about?
This study is a bioequivalence study, which means it compares a new version of a medicine to one that's already approved and commonly used. In this case, the medicine is called lamotrigine. Lamotrigine is an important medication prescribed by doctors to help manage two conditions: epilepsy, which causes seizures, and bipolar disorder, which affects mood.
The new medicine being tested is a dispersible tablet of lamotrigine made by Sun Pharmaceutical. They want to see if it works exactly like the existing Lamictal dispersible tablets. Think of it like comparing two different brands of a common painkiller – the goal is for both to have the same effect, even if they're made by different companies. This study is an important step to make sure any new version of a medicine is just as good as the original.
By ensuring the new tablet acts the same way in your body, researchers can confirm it will be just as effective and safe as the medicine doctors already prescribe. This helps make sure patients always get reliable treatment, no matter which reputable manufacturer makes their medication. It's a standard and necessary part of bringing new medications or new versions of existing medications to people who need them.
Key takeaways
- This study compares a new lamotrigine tablet with an existing one.
- It aims to ensure the new tablet works just as well in the body.
- Healthy adults (18 years and older) are needed as volunteers.
- Participants will take single doses of each tablet and have blood tested.
- This research helps make sure new medicines are safe and effective.
Who may be eligible?
To be considered for this study, you need to be a healthy adult, at least 18 years old. There is no upper age limit, meaning older adults are also welcome to participate as long as they are generally healthy.
This study is open to both men and women. The most important thing is that participants are in good overall health at the time of the study.
This study is for healthy volunteers, not people who are currently being treated for epilepsy or bipolar disorder. This is because the study is designed to see how the medicine acts in the body without other health conditions affecting the results.
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?
- Do you consider yourself generally healthy?
- Are you able to fast (not eat) for a period of time?
- Are you comfortable having blood samples taken several times?
What does participation involve?
If you join this study, you will visit a clinic or research facility. You'll receive a single dose of one lamotrigine tablet, and then, after a short break, you'll receive a single dose of the other lamotrigine tablet. This 'crossover' design allows researchers to compare how your body handles both medications. During these visits, medical staff will take blood samples at specific times to measure how much of the medicine is in your system. This helps them understand how the tablets are absorbed and leave your body. You will be asked to fast (not eat) before taking the medication. The total time you'll spend actively participating in the study, including clinic visits and follow-up, will be clearly explained by the study team.
Potential risks and benefits
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Common questions
What is lamotrigine used for?
Lamotrigine is a medicine used to treat epilepsy (which causes seizures) and bipolar disorder (a condition affecting mood).
What does 'bioequivalence' mean?
It means the study is comparing two versions of the same medicine to see if they work identically in your body.
Do I need to have epilepsy or bipolar disorder to join?
No, this study is for healthy adult volunteers, not people with those conditions.
What will I have to do if I join?
You will take single doses of two different lamotrigine tablets (at separate times) and have blood samples taken to see how your body handles the medicine.
Will I be paid for participating?
Participants in studies like this often receive compensation for their time and travel, but you should confirm this with the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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