Not yet recruiting NCT07643233
Bioequivalence Study of AJU-G721 and G721R in Healthy Adult Volunteers Under Fed Conditions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Test Drug, Reference Drug.
- Who it may be relevant to
- Registry conditions: Moderate-to-severe Benign Prostatic Hyperplasia (BPH). Basic parameters: 19 years — 54 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
To evaluate and compare the safety and pharmacokinetic profiles of "AJU-G721" (test drug) and "G721R" (reference drug) in healthy adult male subjects.
Interventions
- Drug Test Drug
AJU-G721 - Drug Reference Drug
G721R
Primary outcome measures
- Cmax of Tamsulosin. [Time frame: 0 hour ~ 48 hour after drug administration]
- AUCt of Tamsulosin [Time frame: 0 hour ~ 48 hour after drug administration]
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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Bumin Hospital — Seoul
Identifiers
NCT: NCT07643233 · 25BPH11802