Hypertension
Conditions
Brief summary
To evaluate the safety and pharmacokinetic characteristics of AJU-C52H in healthy adults
Detailed description
This study is to assess the safety and pharmacokinetic characteristics between co-administration of C52R1M with C52R2 and administration of AJU-C52H. This is an open-label, randomized, single-dose, 2x2 crossover study in healthy subjects to assess the bioequivalence after taking the study drugs.
Interventions
DRUGC52R1M Tab. and C52R2 Tab.
Single oral dose C52R1M(FDC, Valsartan/Amlodipine) 160/5 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together
DRUGAJU-C52H
Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 160/5/25 mg FDC tablet
Sponsors
AJU Pharm Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCt of AJU-C52 | Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | AUCt: Area under the concentration-time curve from time zero to time |
| Cmax of AJU-C52 | 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: Maximum plasma concentration of the drug |
Countries
South Korea
Contacts
Primary ContactJaewoo Kim, M.D., Ph.D.
Outcome results
None listed