Bioequivalence Study of AJU-G721 and G721R in Healthy Adult Volunteers Under Fed Conditions
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age19-54
SponsorAJU Pharm Co., Ltd.
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Test Drug
DrugAJU-G721
Reference Drug
DrugG721R
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Sequence AExperimental treatment 2 interventions
Group B: Sequence BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Cmax of Tamsulosin.
To assess the maximum observed plasma concentration (Cmax) of Tamsulosin.
Time frame
0 hour ~ 48 hour after drug administration2
AUCt of Tamsulosin
To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Tamsulosin
Time frame
0 hour ~ 48 hour after drug administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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