Bioequivalence (BE) Study Between YHP2511 and YHP2511A in Healthy Volunteers
ConditionHealthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-55
SponsorYuhan Corporation
About this trial
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2511 and YHP2511A in healthy volunteers
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 19 to 55 years at the time of screening visit.
Those whose weight is ≥ 50 kg (≥ 45 kg for females) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination
Those who express their voluntary consent to participate in the trial by signing a written consent
Disqualifiers
Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
Others who are judged ineligible to participate in the trial by the principal investigator
Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.
Trial design
Design model
Crossover
Treatments tested in this trial
YHP2511
DrugTest drug: YHP2511, Comparator: YHP2511A
YHP2511A
DrugTest drug: YHP2511, Comparator: YHP2511A
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: A (RT)Experimental treatment 2 interventions
Group B: B (TR)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Area under the plasma drug concentration-time curve [AUCt]
Area under the plasma drug concentration-time curve \[AUCt\] of Pitavastatin \& Total Ezetimibe
Time frame
Pitavastatin : 0-72 hours, Total Ezetimibe: 0-72 hours2
Maximum plasma concentration [Cmax]
Maximum plasma concentration \[Cmax\] of - Pitavastatin \& Total Ezetimibe
Time frame
Pitavastatin: 0-48 hours, Total Ezetimibe: 0-72 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov