A Clinical Trial to Evaluate the Safety and Pharmacokinetics of AJU-C52H in Healthy Volunteers
NCT ID: NCT05077462
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
60 participants
INTERVENTIONAL
2021-09-17
2022-04-30
Brief Summary
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Detailed Description
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This is an open-label, randomized, single-dose, 2x2 crossover study in healthy subjects to assess the bioequivalence after taking the study drugs.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence A
Period 1: C52R1M(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose Period 2: AJU-C52H(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose
C52R1M Tab. and C52R2 Tab.
Single oral dose C52R1M(FDC, Valsartan/Amlodipine) 160/5 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together
AJU-C52H
Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 160/5/25 mg FDC tablet
Sequence B
Period 1: AJU-C52H(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose Period 2: C52R1M(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose
C52R1M Tab. and C52R2 Tab.
Single oral dose C52R1M(FDC, Valsartan/Amlodipine) 160/5 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together
AJU-C52H
Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 160/5/25 mg FDC tablet
Interventions
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C52R1M Tab. and C52R2 Tab.
Single oral dose C52R1M(FDC, Valsartan/Amlodipine) 160/5 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together
AJU-C52H
Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 160/5/25 mg FDC tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
Yes
Sponsors
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AJU Pharm Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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H+ Yangji Hospital
Seoul, Republic of South Korea, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21HT10602
Identifier Type: -
Identifier Source: org_study_id