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

NCT07231861 | Not Yet Recruiting Phase 1

• 1 other identifier: 25BA11701
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bronchial Asthma; Perennial Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Pranlukast Test Formulation

EXPERIMENTAL

Two-period, single-dose, crossover study

Drug: AJU-R713; Drug: R713R

Pranlukast Reference Formulation

EXPERIMENTAL

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

Drug: AJU-R713; Drug: R713R

Interventions

AJU-R713 DRUG

Oral formulation

Pranlukast Reference Formulation; Pranlukast Test Formulation

R713R DRUG

Oral formulation

Pranlukast Reference Formulation; Pranlukast Test Formulation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AJU Pharm Co., Ltd.: lead

Study Sites (1)

H Plus Yangji Hospital

Seoul, 08779, South Korea

Location

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Heejoo Hong

CONTACT

+82-70-4665-9156; m4688@newyjh.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 17, 2025
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

KR (1)