Bioequivalence Study of AJU-R713 and R713R in Healthy Adult Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorAJU Pharm Co., Ltd.
About this trial
To Evaluate the Safety and Pharmacokinetics of Pranlukast hydrate in Healthy Adults.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults aged 19 years or older at the time of screening.
Body mass index (BMI) between 18 and 30 kg/m².
Male subjects: body weight ≥ 50 kg.
Female subjects: body weight ≥ 45 kg.
Disqualifiers
Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing.
Participation in any clinical trial involving investigational products 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 surgery that may affect drug absorption (excluding appendectomy and hernia repair).
Trial design
Design model
Crossover
Treatments tested in this trial
AJU-R713
DrugOral formulation
R713R
DrugOral formulation
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Pranlukast Test FormulationExperimental treatment 2 interventions
Group B: Pranlukast Reference FormulationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Cmax of Pranlukast
To assess the maximum observed plasma concentration (Cmax) of Pranlukast
Time frame
0 hour ~ 24 hour after drug administration2
AUCt of Pranlukast
To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Pranlukast
Time frame
0 hour ~ 24 hour after drug administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: