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Bioequivalence Study of AJU-G721 and G721R in Healthy Adult Volunteers Under Fed Conditions

NCT07643233 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-06-11

No results posted yet for this study

Summary

To evaluate and compare the safety and pharmacokinetic profiles of "AJU-G721" (test drug) and "G721R" (reference drug) in healthy adult male subjects.

Conditions

  • Moderate-to-severe Benign Prostatic Hyperplasia (BPH)

Interventions

DRUG

Test Drug

AJU-G721

DRUG

Reference Drug

G721R

Sponsors & Collaborators

  • AJU Pharm Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
54 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2026-07-31
Completion
2026-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07643233 on ClinicalTrials.gov