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

An Open-Label, Randomized, Fasting, Single-Dose, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of "AJU-R713" and "R713R" in Healthy Adult Volunteers

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

Study Overview

• Status: Not yet recruiting
• Conditions: Perennial Allergic Rhinitis; Bronchial Asthma
• Intervention / Treatment: Drug: AJU-R713; Drug: R713R

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Heejoo Hong; Phone Number: +82-70-4665-9156; Email: m4688@newyjh.com

Study Locations

• South Korea
  • Seoul, South Korea, 08779
    • H Plus Yangji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pranlukast Test Formulation; Two-period, single-dose, crossover study	Drug: AJU-R713; Oral formulation; Drug: R713R; Oral formulation
Experimental: Pranlukast Reference Formulation; Two-period, single-dose, crossover study (reversed order)	Drug: AJU-R713; Oral formulation; Drug: R713R; Oral formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of Pranlukast	To assess the maximum observed plasma concentration (Cmax) of Pranlukast	0 hour ~ 24 hour after drug administration
AUCt of Pranlukast	To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Pranlukast	0 hour ~ 24 hour after drug administration

Collaborators and Investigators

• Sponsor: AJU Pharm Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Asthma; Rhinitis, Allergic, Perennial; Investigative Techniques; Evaluation Studies as Topic; Drug Development; Drug Evaluation
• Other Study ID Numbers: 25BA11701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No