A Clinical Trial to Evaluate the Safety and Pharmacokinetics of AJU-C52H in Healthy Volunteers

NCT05077462 | Unknown Phase 1

• 1 other identifier: 21HT10602
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and pharmacokinetic characteristics of AJU-C52H in healthy adults

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• AUCt of AJU-C52

  AUCt: 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

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1: C52R1M(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose Period 2: AJU-C52H(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose

Drug: C52R1M Tab. and C52R2 Tab.; Drug: AJU-C52H

Sequence B

EXPERIMENTAL

Period 1: AJU-C52H(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose Period 2: C52R1M(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose

Drug: C52R1M Tab. and C52R2 Tab.; Drug: AJU-C52H

Interventions

C52R1M Tab. and C52R2 Tab. DRUG

Single oral dose C52R1M(FDC, Valsartan/Amlodipine) 160/5 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together

Also known as: Reference Drug

Sequence A; Sequence B

AJU-C52H DRUG

Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 160/5/25 mg FDC tablet

Also known as: Test Drug

Sequence A; Sequence B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AJU Pharm Co., Ltd.: lead

Study Sites (1)

H+ Yangji Hospital

Seoul, Republic of South Korea, South Korea

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Central Study Contacts

Jaewoo Kim, M.D., Ph.D.

CONTACT

+82-70-4665-9193; m3116@newyjh.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 14, 2021
• Study Start: September 17, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

KR (1)