Bioequivalence Study of AJU-R713 and R713R in Healthy Adult Volunteers

Aju Pharm

Status and phase: Not yet enrolling; Phase 1

Conditions: Perennial Allergic Rhinitis; Bronchial Asthma

Treatments: Drug: R713R; Drug: AJU-R713

Study type: Interventional

Funder types: Industry

Identifiers

NCT07231861

25BA11701

Details and patient eligibility

About

To Evaluate the Safety and Pharmacokinetics of Pranlukast hydrate in Healthy Adults.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Pranlukast Test Formulation

Experimental group

Description:

Two-period, single-dose, crossover study

Treatment:

Drug: AJU-R713

Drug: R713R

Pranlukast Reference Formulation

Experimental group

Description:

Two-period, single-dose, crossover study (reversed order)

Treatment:

Drug: AJU-R713

Drug: R713R