Not recruiting

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

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial dose administration
A single oral dose of 10 mg of montelukast is taken under fasting conditions, which means no food is consumed before the administration.
Step 2
Medication comparison
The study compares two different forms of the same medication: montelukast 10 mg capsules and singulair 10 mg film-coated tablets.
Step 3
Crossover period
The study follows a crossover design, meaning the order of receiving the capsules and the tablets is randomized to ensure a fair comparison of how the body absorbs each form.

Who can join the trial?

6 criteria

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 trial?

15 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Hospital Universitario De La Princesa
Madrid, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

Montelukast

What is already known about the treatment

Montelukast
This medication is taken as a hard capsule by mouth and is widely used in medicine to manage asthma and seasonal allergies. It belongs to a group of drugs called leukotriene receptor antagonists, which work by blocking specific chemicals in the body that cause inflammation and swelling in the airways. By preventing these chemicals from attaching to their targets, the drug helps keep the breathing passages open and reduces symptoms.
Montelukast
This medication is taken as a film-coated tablet by mouth and is a well-established treatment for preventing and managing asthma symptoms. As a leukotriene receptor antagonist, it functions at a molecular level by blocking the action of substances in the body that trigger airway narrowing and mucus production. This process helps to reduce inflammation in the lungs, making it easier for the patient to breathe.

Investigated diseases

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.