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

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
C52R1H Tab. and C52R2 Tab.
AJU-C52L
Sponsored by
AJU Pharm Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • H+ Yangji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sequence A

Sequence B

Arm Description

Period 1: C52R1H(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose Period 2: AJU-C52L(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose

Period 1: AJU-C52L(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose Period 2: C52R1H(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose

Outcomes

Primary Outcome Measures

AUCt of AJU-C52
Area under the concentration-time curve from time zero to time
Cmax of AJU-C52
Cmax: Maximum plasma concentration of the drug

Secondary Outcome Measures

Full Information

First Posted
October 1, 2021
Last Updated
October 1, 2021
Sponsor
AJU Pharm Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05077475
Brief Title
A Clinical Trial to Evaluate the Safety and Pharmacokinetics of AJU-C52L in Healthy Volunteers
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 24, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AJU Pharm Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequence A
Arm Type
Experimental
Arm Description
Period 1: C52R1H(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose Period 2: AJU-C52L(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose
Arm Title
Sequence B
Arm Type
Experimental
Arm Description
Period 1: AJU-C52L(FDC tablet, Valsartan/Amlodipine/Chlorthalidone), single dose Period 2: C52R1H(Valsartan/Amlodipine) and C52R2(Chlorthalidone), single dose
Intervention Type
Drug
Intervention Name(s)
C52R1H Tab. and C52R2 Tab.
Other Intervention Name(s)
Reference Drug
Intervention Description
Single oral dose C52R1H(FDC, Valsartan/Amlodipine) 160/10 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together
Intervention Type
Drug
Intervention Name(s)
AJU-C52L
Other Intervention Name(s)
Test Drug
Intervention Description
Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 80/5/12.5 mg FDC 2 tablet
Primary Outcome Measure Information:
Title
AUCt of AJU-C52
Description
Area under the concentration-time curve from time zero to time
Time Frame
Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Title
Cmax of AJU-C52
Description
Cmax: Maximum plasma concentration of the drug
Time Frame
Pre-dose (0 hour), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaewoo Kim
Phone
+827046659193
Email
m3116@newyjh.com
Facility Information:
Facility Name
H+ Yangji Hospital
City
Seoul
State/Province
Republic Of South Korea
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaewoo Kim
Phone
+827046659193
Email
m3116@newyjh.com

12. IPD Sharing Statement

Learn more about this trial

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

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