A Clinical Trial to Evaluate the Safety and Pharmacokinetics of AJU-C52L in Healthy Volunteers

Study Overview
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Brief Summary
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To evaluate the safety and pharmacokinetic characteristics of AJU-C52L in healthy adults

Detailed Description
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This study is to assess the safety and pharmacokinetic characteristics between co-administration of C52R1H with C52R2 and administration of AJU-C52L. This is an open-label, randomized, single-dose, 2x2 crossover study in healthy subjects to assess the bioequivalence after taking the study drugs.

Official Title
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An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AJU-C52L Compared to Coadministration of C52R1H With C52R2 in Healthy Adult Volunteers

Conditions
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Hypertension

Intervention / Treatment
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* Drug: C52R1H Tab. and C52R2 Tab.
* Drug: AJU-C52L


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult volunteers aged ≥ 19-year-old Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2 Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg 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 clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests Those who agree to contraception during the participation of clinical trial Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial Exclusion Criteria: Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug Those who donated whole blood and apheresis within 8 weeks or received transfusion within 4 weeks Those who has a history of gastrointestinal surgery Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30 mL) Smoke: 20 cigarettes/day Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, dihydropyridine sensitivity, angioedema Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests Women who are pregnant or who may be pregnant and breastfeed

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>Period 1: C52R1H(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose Period 2: AJU-C52L(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose | Drug: C52R1H Tab. and C52R2 Tab.<br>* Single oral dose C52R1H(FDC, Valsartan/Amlodipine) 160/10 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together<br>* Other names: Reference Drug;Drug: AJU-C52L<br>* Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 80/5/12.5 mg FDC 2 tablet<br>* Other names: Test Drug;|
| Experimental: Sequence B<br>Period 1: AJU-C52L(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose Period 2: C52R1H(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose | Drug: C52R1H Tab. and C52R2 Tab.<br>* Single oral dose C52R1H(FDC, Valsartan/Amlodipine) 160/10 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together<br>* Other names: Reference Drug;Drug: AJU-C52L<br>* Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 80/5/12.5 mg FDC 2 tablet<br>* Other names: Test Drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of AJU-C52 | Area under the concentration-time curve from time zero to time | Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | 
| Cmax of AJU-C52 | Cmax: Maximum plasma concentration of the drug | Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours |