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CRIS문의

  • Status : Approved
    • First Submitted Date : 2019/09/02
    • Registered Date : 2019/09/10
    • Last Updated Date : 2019/09/09
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1. Background

Background Information
CRIS
Registration Number
KCT0004290 
Unique Protocol ID INHAUH 2019-03-006 
Public/Brief Title Phase I clinical trial to compare the pharmacokinetics and safety of RDN18002 with co-administration of sitagliptin and empagliflozin in healthy adult volunteers 
Scientific Title Phase I clinical trial to compare the pharmacokinetics and safety of RDN18002 with co-administration of sitagliptin and empagliflozin in healthy adult volunteers  
Acronym HU-048_P1 
MFDS Regulated Study Yes
IND/IDE Protocol Yes
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Not applicable

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number INHAUH 2019-03-006-001 
Approval Date 2019-04-22 
Institutional Review Board  
Name Inha University Hospital IRB 
Address 27, Inhang-ro, Jung-gu, Incheon 
Telephone 032-890-3691 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Sang-Heon Cho 
Title Associate Professor 
Telephone +82-32-890-1122 
Affiliation Inha University Hospital 
Address 27, Inhang-ro, Jung-gu, Incheon, 22332, Rep. of KOREA 
Contact Person for Public Queries
Name Mi-hwa Ji 
Title CRC 
Telephone +82-32-890-1169 
Affiliation Inha University Hospital 
Address 27, Inhang-ro, Jung-gu, Incheon, 22332, Rep. of KOREA 
Contact Person for Updating Information
Name Jihye Na 
Title Manager 
Telephone +82-70-7492-5735 
Affiliation Huons 
Address 253, Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13486, Rep. of KOREA 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2019-06-20 , Actual
Target Number of Participant 40
Primary Completion Date 2019-07-08 , Actual
Study Completion Date 2019-07-08 , Actual
Recruitment Status by Participating Study Site 1
Name of Study Site Inha University Hospital 
Recruitment Status Completed  
Date of First Enrollment 2019-06-20 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Huons 
Organization Type Pharmaceutical Company  
Project ID HU-048_P1 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Huons 
Organization Type Pharmaceutical Company  

7. Study Summary

Study Summary Information
Lay Summary 1) Purpose: clinical trial to compare the pharmacokinetics and safety of RDN18002 with co-administration of sitagliptin and empagliflozin in healthy adult volunteers <br />2) Target disease: type 2 diabetes patients <br />3) End points: <br />-PK : AUCt, Cmax of Sitagliptin & Empagliflozin(Primary) / AUCinf, Tmax, t1/2 of Sitagliptin & Empagliflozin(second) <br />-Safety : Adverse event, Physical examination, Vital sign, ECG, Clinical laboratory test, Blood sugar test(POCT)  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Treatment    
Phase Phase1 
Intervention Model Cross-over  
Blinding/Masking Open 
Allocation RCT 
Intervention Type Drug  
Intervention Description 1. Sequence A : Period 1 R administration -&gt; Period 2 T administration / Wash out : 7 days <br />2. Sequence B : Period 1 T administration -&gt; Period 2 R administration / Wash out : 7 days <br />* R(Comparator drug): sitagliptin 1 tablet + empagliflozin 1 tablet, Single oral administration <br />* T(Test drug): RDN18002 1 tablet, Single oral administration  
Number of Arms
Arm 1 Arm Label Sequence A 
Target Number of Participant 20 
Arm Type Others 
Arm Description 1 period: Sitaglitpin 1 tablet + Empagliflozin 1 tablet, Single Oral Administration 2 period: RDN18002 1 tablet. Single Oral Administration * washout period : 7 days 
Arm 2 Arm Label Sequence B 
Target Number of Participant 20 
Arm Type Others 
Arm Description 1 period: RDN18002 1 tablet. Single Oral Administration 2 period: Sitaglitpin 1 tablet + Empagliflozin 1 tablet, Single Oral Administration * washout period : 7 days 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Endocrine, nutritional and metabolic disease
 Healthy adult
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ 45 Year
Description 1) Healthy adult subject older than 19 to 45 years at the time of screening <br />2) Body weight more than 50kg and Body Mass Index(BMI) 18.0kg/m2 ~ 29.0 kg/m2 <br />☞ BMI(kg/m2) = Body weight (kg) / {height (m)}2 <br />3) Subject judged to be eligible by Physical examination and interview conducted according to the study protocol. Thus, subject should not have congenital/chronic disease or pathological symptoms/findings <br />4) Subject judged to be eligible by clinical laboratory tests such as hematology test, blood chemistry test, serum electrolyte test, urine test, Urine Microscopy urine test, serology test performed according to the study protocol <br />5) Subject who fully understands the clinical trials after in-depth explanation, volunteers to join the clinical trials and signs inform consent  
Exclusion Criteria 1) Subject with currently or a history of cardiovascular , respiratory, hepatic, renal, neurological, endocrine, hemato-oncology, psychiatric, urinary diseases that is clinically significant <br />2) Subject with a history of pancreatitis <br />3) Subject with Type 1 diabetes or diabetic ketoacidosis <br />4) Subject with a history of gastrointestinal disorders (Crohn&#39;s disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of pharmaceuticals for clinical trials <br />5) Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption <br />6) Subject with with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs including sitagliptin, empagliflozin or other drugs (including aspirin, antibiotics, etc) <br />7) Systolic blood pressure ≤100mmHg or ≥ 150mmHg, diastolic blood pressure ≤55mmHg or ≥ 95mmHg at the time of screening <br />8) Subject with the following results in the clinical laboratory tests <br />- Aspartate Transaminase(AST) or Alanine Transaminase(ALT) &gt; 2 x upper limit of normal range <br />- Total Bilirubin &gt; 2.0 mg/dl <br />- CK &gt; 2 x upper limit of normal range <br />- eGFR &lt; 60 mL/min/1.73m2 <br />9) Subject who takes alcohol &gt; 21 units/week, 1unit=10g=12.5ml of pure alcohol) or can’t stop drinking during the clinical trials <br />10) Subject who smokes&gt; 10 cigarettes/day or can’t stop smoking during the clinical trials <br />11) Subject who have received medication involved in other clinical trials within 6 months before the first administration <br />12) Subject who have donated whole blood donation within 60 days, component blood donation within 30 days or have received blood transfusions before the first administration <br />13) Subject taking any ETC or herbal medicine, within 2 weeks or taking any OTC within 1weeks before the first administration (However, if the drug does not affect the pharmacokinetic properties of the clinical trial drug, it may be taken at the discretion of the Investigator.) <br />14) Subject taking metabolizing enzyme inducers or inhibitors such as barbitals within 1 month before the first administration <br />15) Subject with mental illness or substance abuse <br />16) Subject who have consumed food which can significantly change the absorption, distribution, metabolism and excretion of a Investigational drug within 7 days before the first administration (such as grapefruit or its components) <br />17) Subject who do not agree with the approved method of contraception during the clinical trial <br />* Approved method of contraception: Blockage(condoms, Diaphragm etc.) with other contraception(infertility operation, intrauterine contraceptive device, oral contraceptive pill, hormone, contraceptive cream, jelly or foam etc.) <br />18) Subject deemed inappropriate to participate in the clinical trial for clinical laboratory test results or other reasons <br />19) Female subject with pregnancy, serum/urine hCG Positive or breast-feeding  
Healthy Volunteers Yes

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Pharmacokinetics 
Primary Outcome(s) 1 
Outcome AUCt of sitagliptin and empagliflozin 
Timepoint 0, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h after administration 
Primary Outcome(s) 2 
Outcome Cmax of of sitagliptin and empagliflozin 
Timepoint 0, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h after administration 
Secondary Outcome(s) 1 
Outcome AUCinf of of sitagliptin and empagliflozin 
Timepoint 0, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h after administration 
Secondary Outcome(s) 2 
Outcome Tmax of of sitagliptin and empagliflozin 
Timepoint 0, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h after administration 
Secondary Outcome(s) 3 
Outcome T1/2 of of sitagliptin and empagliflozin 
Timepoint 0, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h after administration 

11. Study Results and Publication

Study Results and Publication Information
Result Registered No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement No 
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