Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2026-01-09 @ 6:12 AM
Study NCT ID:
NCT07231861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of AJU-R713 and R713R in Healthy Adult Volunteers
Sponsor:
AJU Pharm Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: