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

Aju Pharm

Status and phase: Unknown; Phase 1

Conditions: Hypertension

Treatments: Drug: AJU-C52L; Drug: C52R1H Tab. and C52R2 Tab.

Study type: Interventional

Funder types: Industry

Identifiers

NCT05077475

21HT10603

Details and patient eligibility

About

To evaluate the safety and pharmacokinetic characteristics of AJU-C52L in healthy adults

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adult volunteers aged ≥ 19-year-old
2. Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
3. 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
4. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
6. Those who agree to contraception during the participation of clinical trial
7. 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

1. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
2. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
3. Those who donated whole blood and apheresis within 8 weeks or received transfusion within 4 weeks
4. Those who has a history of gastrointestinal surgery
5. 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
6. Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, dihydropyridine sensitivity, angioedema
7. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
9. Women who are pregnant or who may be pregnant and breastfeed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Sequence A

Experimental group

Description:

Period 1: C52R1H(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose Period 2: AJU-C52L(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose

Treatment:

Drug: C52R1H Tab. and C52R2 Tab.

Drug: AJU-C52L

Sequence B

Experimental group

Description:

Period 1: AJU-C52L(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose Period 2: C52R1H(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose

Treatment:

Drug: C52R1H Tab. and C52R2 Tab.

Drug: AJU-C52L