NCT07231861

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: AJU Pharm Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bronchial Asthma
• Perennial Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	AJU-R713	Oral formulation
DRUG	R713R	Oral formulation

Timeline

• Start date: 2025-12-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-11-17
• Last updated: 2025-11-19

Locations

1 site across 1 country: South Korea