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

NCT07643233 — Phase 1, Not yet recruiting, 36 participants, AJU Pharm Co., Ltd.

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An Open-Label, Randomized, Fed, Single-Dose, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of "AJU-G721" and "G721R" in Healthy Adult Male Subjects

Registry	NCT07643233
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	36 (Estimated)
Sponsor	AJU Pharm Co., Ltd. (Industry)
Conditions	Moderate-to-severe Benign Prostatic Hyperplasia (BPH)
Interventions	Test Drug, Reference Drug (Drug)
Dates	start 2026-07-01 (estimated), primary completion 2026-07-01 (estimated), completion 2026-08-01 (estimated), first posted 2026-06-11, last updated 2026-06-11
Locations	1 site in South Korea

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Sequence A	Experimental	Drug: Test Drug; Drug: Reference Drug	Period 1: Reference Drug, Single dose/ Period 2: Test Drug, Single dose
Sequence B	Experimental	Drug: Test Drug; Drug: Reference Drug	Period 1: Test Drug, Single dose/ Period 2: Reference Drug, Single dose

Test Drug (Drug): AJU-G721
Reference Drug (Drug): G721R

+Outcome measures

Primary outcomes

Cmax of Tamsulosin. [0 hour ~ 48 hour after drug administration]: To assess the maximum observed plasma concentration (Cmax) of Tamsulosin.
AUCt of Tamsulosin [0 hour ~ 48 hour after drug administration]: To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Tamsulosin

+Eligibility

Sex: Male, ages: 19 Years to 54 Years, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

+Locations (1)

Facility	City	Country	Status
Bumin Hospital	Seoul	South Korea