Systemic Bioavailability and Bioequivalence of Topical Diclofenac Fysioline 23.2 mg/g gel compared with Diclofenac Diethylamine - Voltaren Forte 2.32% gel
Muscle and joint pain are very common, and many people use anti-inflammatory gels rubbed directly onto the skin for relief. Diclofenac is a well-known painkiller used in these treatments. This clinical trial is testing a gel called Diclofenac Fysioline (23.2 mg/g) against an existing, widely used brand called Voltaren Forte (2.32% gel). The goal is to find out if both gels are 'bioequivalent'. This means checking whether the body absorbs the same amount of medicine from each gel at a similar speed. By comparing blood samples after applying each product, scientists can ensure the new version is just as safe, reliable, and effective as the brand people already know. Studies like this are essential because they can help introduce more affordable, high-quality treatment choices for people managing everyday pain.
At a glance
What is this study about?
Many of us experience joint stiffness, sprains, or muscle aches at some point in our lives. Often, the first port of call is a gel or cream rubbed directly onto the painful area. One of the most common medicines used for this is diclofenac, a non-steroidal anti-inflammatory drug (NSAID) that reduces swelling and relieves discomfort. This study looks closely at how two different brands of diclofenac gel behave when applied to the skin.
The researchers are comparing a newer gel, Diclofenac Fysioline, against a well-known brand, Voltaren Forte. Both products contain the exact same strength of the active pain-relieving ingredient (2.32%). The main aim of the trial is to see if they are 'bioequivalent'. In simple terms, this means checking whether your body absorbs the medicine from the new gel in the exact same way and at the same rate as the standard version.
To test this, healthy volunteers will try the gels so researchers can measure tiny amounts of the medicine that enter the bloodstream. While topical gels are designed to work mainly on the skin and tissues underneath, checking blood levels is the gold standard way to prove two medicines perform identically. If the trial shows the two gels match closely, it means doctors and patients can be confident the new brand works just as well as the original.
Key takeaways
- Tests whether a new diclofenac gel works the same way as Voltaren Forte.
- Both products contain 2.32% of the active anti-inflammatory medicine.
- Involves clinic visits, gel application, and scheduled blood tests.
- Open to adults aged 18 and over who meet the health criteria.
- Helps make more safe, proven pain relief options available to the public.
Who may be eligible?
This study is open to adults aged 18 and older, including both men and women. In general, early-stage trials like this look for healthy volunteers whose bodies can process the medicine normally, without interference from other illnesses.
While full details are confirmed during screening, you typically cannot take part if you have a known allergy or sensitivity to diclofenac, aspirin, or other anti-inflammatory drugs. You may also be excluded if you have broken or damaged skin where the gel needs to be applied, or serious ongoing health conditions affecting your kidneys, liver, or stomach.
Women who are pregnant, planning a pregnancy, or breastfeeding are usually not able to join. The study medical team will check your full medical history and perform standard health checks to confirm whether it is safe for you to take part.
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.
- I am aged 18 or older.
- I do not have allergies to diclofenac, aspirin, or NSAID painkillers.
- My skin is healthy and free from rashes, cuts, or eczema.
- I am not currently pregnant or breastfeeding.
- I am happy to attend clinic visits and have routine blood samples taken.
What does participation involve?
Taking part in this study involves visiting a specialist research clinic. Before starting, doctors will perform routine health checks, such as blood pressure tests and a physical exam, to make sure you are fit to join. During the trial, you will have a measured amount of each gel applied to your skin at separate times, allowing the researchers to compare them directly.
You will need to give blood samples at regular intervals throughout the day after the gel is applied. This allows the laboratory team to track how much medicine enters your system over time. You will likely spend some time resting at the clinic while these checks take place. The team will monitor you closely for any skin irritation or side effects before you are discharged, and a brief follow-up check may be arranged to ensure you feel well.
Potential risks and benefits
Locations (1)
- —UnverifiedFinland
Common questions
What is the difference between the two gels?
Both gels contain the same active painkiller (diclofenac) at the same strength. They are simply made by different manufacturers, and this study checks if they perform identically.
Why do you need blood tests for a skin gel?
Even though the gel acts on the skin, tiny amounts absorb into the blood. Measuring this is the most accurate scientific way to prove both gels release medicine at the same speed.
Will taking part cure my joint pain?
Not necessarily. This study is designed to measure how the medicine behaves in the body rather than provide long-term treatment for a specific injury.
Is the gel safe to use?
Diclofenac gels have been used safely by millions of people for many years. The study team will also monitor you closely to manage any mild skin reactions.
Can I leave the trial if I change my mind?
Yes. Joining a clinical trial is always your choice, and you can withdraw at any point without it affecting your normal medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.