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

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

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

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Drug: C52R1H Tab. and C52R2 Tab.; Drug: AJU-C52L

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jaewoo Kim; Phone Number: +827046659193; Email: m3116@newyjh.com

Study Locations

• Korea, Republic of
  • Republic Of South Korea
    • Seoul, Republic Of South Korea, Korea, Republic of
      • Recruiting
      • H+ Yangji Hospital
      • Contact: Jaewoo Kim; Phone Number: +827046659193; Email: m3116@newyjh.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AJU Pharm Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antimitotic Agents; Mitosis Modulators; Cryptophycin 52
• Other Study ID Numbers: 21HT10603

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No