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

NCT07643220 | Recruiting Phase 1

• 1 other identifier: 25BPH11801
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (2)

• Cmax of Dutasteride and Tamsulosin.

  To assess the maximum observed plasma concentration (Cmax) of Dutasteride and Tamsulosin.

  [Time Frame: 0 hour ~ 72 hour after drug administration]

• AUCt of Dutasteride and Tamsulosin

  To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Dutasteride and Tamsulosin

  [Time Frame: 0 hour ~ 72 hour after drug administration]

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1: Reference Drug, Single dose/ Period 2: Test Drug, Single dose

Drug: Test Drug; Drug: Reference Drug

Sequence B

EXPERIMENTAL

Period 1: Test Drug, Single dose/ Period 2: Reference Drug, Single dose

Drug: Test Drug; Drug: Reference Drug

Interventions

Test Drug DRUG

AJU-G721

Sequence A; Sequence B

Reference Drug DRUG

G721R

Sequence A; Sequence B

Eligibility Criteria

• Age: 19 Years - 54 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• AJU Pharm Co., Ltd.: lead

Study Sites (1)

Bumin Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

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: June 8, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

KR (1)