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New asthma drug formulation put to the test in healthy adults

NCT ID NCT07231861

Knowledge-focused Sponsor: AJU Pharm Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study compares two oral formulations of pranlukast, a drug used for asthma and allergic rhinitis, to see if they are equivalent. Sixty healthy adults will receive a single dose of each version in random order under fasting conditions. The main goal is to measure drug levels in the blood, not to treat any condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pranlukast hydrate
What this could lead to
If successful, this study could confirm that the new formulation of pranlukast works the same as the existing one, potentially offering a generic alternative for asthma and allergy treatment.
What could go wrong
This is an early Phase 1 trial in healthy volunteers, not patients. It only checks drug levels in the blood, not whether the drug actually helps symptoms. The results may not predict real-world effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

62 people

The number who actually took part.

Started

Dec 2025

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Healthy adults aged 19 years or older at the time of screening. * Body mass index (BMI) between 18 and 30 kg/m². * Male subjects: body weight ≥ 50 kg. * Female subjects: body weight ≥ 45 kg. * Clinically healthy based on medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory test results, as determined by the investigator. * Willing and able to provide written informed consent after receiving a full explanation of the study. * Subjects (and their partners, if applicable) agree to use highly effective, non-hormonal contraception from the first dosing day until one week after the last dose. Exclusion Criteria: * Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing. * Participation in any clinical trial involving investigational products within 6 months prior to the first dose. * Whole blood donation within 8 weeks, or component blood donation within 2 weeks prior to the first dose. * History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair). * Known hypersensitivity to the investigational product or its components. * Known metabolic or genetic disorders such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption, or phenylketonuria. * History of clinically significant psychiatric illness. * Pregnant or breastfeeding women, or women with a possibility of pregnancy.

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Conditions

The condition(s) this trial relates to.

asthma perennial allergic rhinitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bronchial asthma Perennial allergic rhinitis

Contacts and locations

Locations

  • H Plus Yangji Hospital

    Seoul, 08779, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.