An open label, balanced, randomized, single dose, two-treatment, four period, two-sequence, crossover, fully replicate, bioequivalence study comparing Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablet USP 180 mg/240 mg, Manufactured by: Sun Pharmaceutical Industries Limited, India with Allegra-D® 24 HR (Fexofenadine HCl and Pseudoephedrine HCl Extended Release Tablets 180 mg + 240 mg) tablets, Distributed by: Chattem Inc., a Sanofi Company Chattanooga, TN 37409-0219, USA, in healthy, adult, human participants under fasting conditions.
This clinical trial is testing two allergy medicines designed to relieve hay fever and nasal congestion. Both tablets contain two active ingredients: fexofenadine, which calms allergy symptoms like sneezing and itchy eyes, and pseudoephedrine, a decongestant that clears blocked sinuses. One tablet is a well-known brand named Allegra-D 24 HR. The other is a generic version made by Sun Pharmaceutical Industries. The trial aims to prove 'bioequivalence'. This means showing that the generic tablet releases the medicine into the bloodstream at the same speed and in the same amount as the original brand. Healthy adult volunteers will take single doses of each tablet on an empty stomach across four different study visits. Regular blood samples will track how the body processes each medicine. If the results match, the generic tablet can be approved as an effective, affordable alternative.
At a glance
What is this study about?
Hay fever, also known as seasonal allergic rhinitis, affects millions of people each year. It causes frustrating symptoms such as itchy eyes, constant sneezing, and a blocked or runny nose. Tablets that combine an antihistamine (to stop the allergic reaction) with a decongestant (to clear the nasal passages) offer powerful 24-hour relief. Allegra-D 24 HR is a well-established brand that uses this combination.
When brand-name medicines have been used safely for years, other manufacturers can make generic versions. These generic tablets contain identical active ingredients in the exact same doses. Because they are usually much cheaper to produce, they help keep medication costs down for patients and healthcare services alike.
Before a generic medicine can be sold, health authorities require strict proof that it works identically to the original. This is called a bioequivalence study. Researchers measure how the tablet dissolves, enters the blood, and leaves the body. This trial ensures that patients switching to the generic tablet will get the exact same relief and safety as they would from the brand-name version.
Key takeaways
- The trial compares a generic allergy pill to the brand-name Allegra-D 24 HR.
- Both tablets contain fexofenadine for allergies and pseudoephedrine for congestion.
- Open to healthy adults aged 18 and over.
- Volunteers take single doses across four separate visits after an overnight fast.
- Regular blood tests check that both tablets enter the bloodstream in the same way.
- Participation is entirely voluntary with no direct medical treatment benefit.
Who may be eligible?
This trial is open to healthy adult volunteers aged 18 and older. Both men and women are welcome to take part. Because the goal is simply to measure how the human body handles the tablet, participants should generally be in good overall health rather than actively suffering from severe medical conditions.
People with certain health issues will not be able to join. Because pseudoephedrine can increase heart rate and blood pressure, anyone with heart disease, high blood pressure, or thyroid problems is usually excluded. Those with kidney problems or known allergies to these medications will also be unable to take part.
Women who are pregnant, planning to become pregnant, or breastfeeding will not be eligible. Volunteers will also need to be comfortable fasting overnight before taking the medicine and willing to have routine blood samples taken throughout the study.
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 consider myself to be in good general health.
- I do not have high blood pressure, heart disease, or kidney problems.
- I am not pregnant, planning a pregnancy, or breastfeeding.
- I am willing to fast overnight and have routine blood samples taken.
What does participation involve?
Taking part involves attending a specialist clinic over four separate periods. During each period, you will fast overnight (no food for several hours) and then take a single tablet with a glass of water. You will remain under observation at the clinic while staff take small blood samples from your arm at set times over 24 to 48 hours to measure medicine levels.
Between each visit, there will be a resting gap called a 'washout period' lasting at least one to two weeks. This break ensures the medicine completely leaves your system before the next dose. Because this is a 'crossover' study, you will try both the brand and generic tablets during the trial. The entire study usually takes several weeks to complete from your first health screening to your final check-up.
Potential risks and benefits
Locations (1)
- —UnverifiedRomania
Common questions
What does 'bioequivalence' mean?
It means proving that a generic medicine releases the same amount of active ingredient into your blood at the same speed as the original brand.
Do I need to have hay fever to take part?
No. This study looks at how healthy bodies absorb the medicine, so you do not need to have active allergies to join.
Why do I have to fast before taking the tablet?
Food can change how quickly a stomach absorbs medicine. Fasting ensures that everyone takes the tablet under the exact same conditions.
Will taking pseudoephedrine keep me awake?
Pseudoephedrine is a decongestant that can act as a mild stimulant for some people, causing temporary alertness, restlessness, or difficulty sleeping.
Can I leave the study if I change my mind?
Yes. Taking part is completely voluntary. You can withdraw at any time, and your decision will always be respected.
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.