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

Recruiting now · Phase 1

Conditions studied: Moderate-to-severe Benign Prostatic Hyperplasia (BPH)

In brief

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

Key facts

Study ID: NCT07643220
Run by: AJU Pharm Co., Ltd.
People needed: 44
Starts: 2026-06-01
Expected to finish: 2026-07-01
Last updated by the study team: 2026-06-12

Who can join

Age: 19 and older, up to 54. Sex: male. Healthy volunteers: accepted.

You may qualify if…

Healthy male adults aged ≥19 years and <55 years at screening.
Body weight ≥ 50 kg and body mass index (BMI) between 18 and 30 kg/m².
Clinically healthy based on medical history, physical examination, ECG, and laboratory test results, as determined by the investigator.
Willing and able to provide written informed consent.
Agrees to use medically acceptable contraception during the required study period.

You may not qualify if…

Use of medications known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or other medications that may interfere with the study within 10 days prior to dosing.
Participation in another clinical trial involving an investigational product 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 resection that may affect drug absorption.
Known hypersensitivity to dutasteride, tamsulosin, or any component of the investigational product.
History of psychiatric illness, or any condition considered unsuitable for study participation by the investigator.

Where it is running

Bumin Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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