Comparison of montelukast 10 mg capsules and montelukast 10 mg film-coated tablets in healthy volunteers to evaluate how the medicine is absorbed.

1 1 1

What is this study about?

This study focuses on Asthma, a condition that affects the airways in the lungs. The goal is to determine if a new version of the medication montelukast works in the same way as the widely used brand-name version. The study will compare montelukast in 10 mg capsules, which are small containers filled with medication, against 10 mg film-coated tablets, which are solid pieces of medication covered in a thin layer.

The research is a crossover study, which means that participants will receive both types of medication at different times during the trial. To ensure accurate results, the medication will be taken as a single oral dose, meaning it is swallowed by mouth, while the participants are in a fasting state, meaning they have not eaten for a certain period. This process is used to check bioequivalence, which is a way to confirm that two different drug versions release the same amount of medicine into the body at a similar rate.

Who Can Join the Study?

You must be a man or a woman who agrees to take part in the study by providing written consent, which is a signed document showing you understand the study goals, risks, and your right to stop at any time.
You must be between 18 and 55 years old.
You must not have any important organic conditions, which are physical health problems involving your organs, or psychic conditions, which are mental health concerns.
Your medical records and physical examination, which is a routine checkup by a healthcare professional, must show no significant health issues.
Your haematology (blood study), coagulation (the blood’s ability to clot), biochemistry (the study of chemical processes in the body), serology (testing for infections like Hepatitis B, Hepatitis C, and HIV), and urinalysis (a urine test) must all show normal results.
Your vital signs, such as blood pressure and heart rate, and your electrocardiogram, which is a test that records the electrical activity of your heart, must be normal.

Who Cannot Join the Study?

People with any physical or mental health conditions.
People whose blood tests show issues with their liver or kidneys. This means levels of certain chemicals in the blood, such as GOT, GPT, GGT, or bilirubin (substances produced by the liver), are higher than the normal range.
People who have taken an experimental medicine (a drug being tested in a study) within the last 3 months.
People who are unable to follow instructions or work with the study team.
People with a history of difficulty swallowing.
People with lactose intolerance (the inability to digest the sugar found in milk).
People with rare inherited conditions that make it hard to process certain sugars like galactose or glucose.
People who have taken prescription medicine in the last 15 days or any medicine in the 48 hours before the study begins. Note that women can use contraceptives (birth control), but they must have used the same method for at least 4 weeks before joining.
People whose Body Mass Index (BMI)—a measurement of weight relative to height—is lower than 18.5 or higher than 30.0.
People with a history of allergic reactions or sensitivity to any medicine.
People who test positive for illegal drugs, such as cannabis, opiates, cocaine, or amphetamines.
People who smoke.
People who drink alcohol every day or have experienced alcohol poisoning (a dangerous reaction to too much alcohol) in the last week.
People who have donated blood within the last month.
People who are pregnant or breastfeeding.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Hdsqmmzd Usvcxaxyzhnuc De La Pfwbplvo	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	15.09.2023

Trial locations

Investigated drugs:

Montelukast

Montelukast is a medication used to prevent asthma attacks and manage symptoms of allergies. In this study, it is being tested to see how well it is absorbed by the body when taken in capsule form.

Montelukast is also being used as a comparison medication in its tablet form. This helps researchers determine if the capsule version works in a similar way to the standard tablets already available on the market.

Investigated diseases:

Asthma

Asthma – This is a condition that affects the airways in the lungs. The airways become narrow and swollen due to inflammation. This swelling can cause the muscles around the airways to tighten. As the condition progresses, these changes can make it more difficult for air to move in and out of the lungs. Symptoms often occur in episodes or attacks.

Trial ID:

2023-506937-30-00

Protocol code:

UECHUP-MON/23-4

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

Other Trials to Consider

#1 Clinical Trials Search in Europe

Comparison of montelukast 10 mg capsules and montelukast 10 mg film-coated tablets in healthy volunteers to evaluate how the medicine is absorbed.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?