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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05077475
• Other study ID #: 21HT10603
• Status: Recruiting
• Phase: Phase 1
• Start date: September 24, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: October 2021
• Source: AJU Pharm Co., Ltd.
• Contact: Jaewoo Kim
• Phone: +827046659193
• Email: m3116[@]newyjh.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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
• AJU-C52L
Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 80/5/12.5 mg FDC 2 tablet

Locations

Country	Name	City	State
Korea, Republic of	H+ Yangji Hospital	Seoul	Republic Of South Korea

Sponsors (1)

Lead Sponsor	Collaborator
AJU Pharm Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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