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

Recruiting Phase 1 Interventional Study
Moderate-to-severe Benign Prostatic Hyperplasia (BPH)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
19 – 54
Sex
Male
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
44 (estimated)
Sponsor
AJU Pharm Co., Ltd. · Industry
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About This Trial

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

Trial Locations
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Eligibility Criteria
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. * …
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