NCT07643220RecruitingPhase 1
An Open-Label, Randomized, Fasting, Single-Dose, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of "AJU-G721" and "G721R" in Healthy Adult Male Subjects
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- AJU Pharm Co., Ltd.
- Enrollment
- 44
- Locations
- 2
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 54 Years (Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
Sequence A
Experimental
Period 1: Reference Drug, Single dose/ Period 2: Test Drug, Single dose
Intervention: Test Drug (Drug)
Sequence A
Experimental
Period 1: Reference Drug, Single dose/ Period 2: Test Drug, Single dose
Intervention: Reference Drug (Drug)
Sequence B
Experimental
Period 1: Test Drug, Single dose/ Period 2: Reference Drug, Single dose
Intervention: Test Drug (Drug)
Sequence B
Experimental
Period 1: Test Drug, Single dose/ Period 2: Reference Drug, Single dose
Intervention: Reference Drug (Drug)
Investigators
Study Sites (2)
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