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

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07643233

Enrollment

Registered

2026-06-11

Start date

2026-07-01

Completion date

2026-08-01

Last updated

2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate-to-severe Benign Prostatic Hyperplasia (BPH)

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.

Interventions

DRUGTest Drug

AJU-G721

DRUGReference Drug

G721R

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 54 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026