Health TrialsbyHealthPanel

Bioequivalence Study of AJU-C715 and C715R in Healthy Adult Volunteers

ConditionsHypercholerolemiaDyslipidemia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-59
SponsorAJU Pharm Co., Ltd.

About this trial

To Evaluate the Safety and Pharmacokinetics of "AJU-C715" and "C715R" in Healthy Adults.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adults aged 19 to less than 60 years at the time of screening

Weight ≥ 50 kg for men or ≥ 45 kg for women, with a calculated body mass index(BMI) of 18 to 30 kg/m² at the time of screening.

Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings.

Those who are eligible for the clinical trial based on laboratory test results(hematology, blood chemistry, serum, and urine tests) and 12-lead ECG findings during screening.

Disqualifiers

Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month or the first administration of clinical trial drug within 10 days.

Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug. 3. Those who donated whole blood within 8 weeks, received apheresis within 2 weeks, blood transfusion within 1 month or can't refrain from donating blood from the time of written consent until the end of the study.

Those who are hypersensitive to component of the Investigational product and have the medical history

Those with active liver disease or persistent elevation of aminotransferase levels of unknown

Trial design

Design model

Crossover

Treatments tested in this trial

  • Test Drug

    Drug

    AJU-C715

  • Reference Drug

    Drug

    C715R

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Sequence AExperimental treatment 2 interventions
Group B: Sequence BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

AUCt of AJU-C715

Time frame
Pre-dose(0 hours) ~ 72 hours
2

Cmax of AJU-C715

Time frame
Pre-dose(0 hours) ~ 72 hours

Secondary outcomes

1

AUC∞ of AJU-C715

Time frame
Pre-dose(0 hours) ~ 72 hours
2

AUCt/AUC∞ of AJU-C715

Time frame
Pre-dose(0 hours) ~ 72 hours
3

Tmax of AJU-C715

Time frame
Pre-dose(0 hours) ~ 72 hours
4

t1/2 of AJU-C715

Time frame
Pre-dose(0 hours) ~ 72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AJU Pharm Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: