Bronchial Asthma, Perennial Allergic Rhinitis
Conditions
Brief summary
To Evaluate the Safety and Pharmacokinetics of Pranlukast hydrate in Healthy Adults.
Detailed description
This study evaluates the pharmacokinetic characteristics and safety of pranlukast in healthy adults. It is a randomized, open-label, single-dose, two-period crossover trial conducted under fasting conditions. Pharmacokinetic samples are collected up to 24 hours after dosing, and standard safety assessments are performed throughout the study.
Interventions
DRUGAJU-R713
Oral formulation
DRUGR713R
Oral formulation
Sponsors
AJU Pharm Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of Pranlukast | 0 hour ~ 24 hour after drug administration | To assess the maximum observed plasma concentration (Cmax) of Pranlukast |
| AUCt of Pranlukast | 0 hour ~ 24 hour after drug administration | To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Pranlukast |
Countries
South Korea
Outcome results
None listed