Status Approved
First Submitted Date
2019/09/02
Registered Date
2019/09/10
Last Updated Date
2019/09/09
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0004290 |
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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
Board Approval Status | Submitted approval |
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Board Approval Number | INHAUH 2019-03-006-001 |
Approval Date | 2019-04-22 |
Institutional Review Board Name | Inha University Hospital IRB |
Institutional Review Board Address | 27, Inhang-ro, Jung-gu, Incheon |
Institutional Review Board Telephone | 032-890-3691 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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 | Inha University Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2019-06-20 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Huons |
Organization Type | Pharmaceutical Company |
Project ID | HU-048_P1 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Huons |
Organization Type | Pharmaceutical Company |
7. Study Summary
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 2) Target disease: type 2 diabetes patients 3) End points: -PK : AUCt, Cmax of Sitagliptin & Empagliflozin(Primary) / AUCinf, Tmax, t1/2 of Sitagliptin & Empagliflozin(second) -Safety : Adverse event, Physical examination, Vital sign, ECG, Clinical laboratory test, Blood sugar test(POCT) |
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8. Study Design
Study Type | Interventional Study |
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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 -> Period 2 T administration / Wash out : 7 days 2. Sequence B : Period 1 T administration -> Period 2 R administration / Wash out : 7 days * R(Comparator drug): sitagliptin 1 tablet + empagliflozin 1 tablet, Single oral administration * T(Test drug): RDN18002 1 tablet, Single oral administration |
Number of Arms | 2 |
Arm 1 |
Arm Label Sequence A |
Target Number of Participant 20 |
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Arm Type Others |
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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 |
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Arm 2 |
Arm Label Sequence B |
Target Number of Participant 20 |
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Arm Type Others |
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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
Condition(s)/Problem(s) |
* (E00-E90)Endocrine, nutritional and metabolic diseases (E11.9)Type 2 diabetes mellitus, without complications Healthy adult |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~45Year |
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Description 1) Healthy adult subject older than 19 to 45 years at the time of screening 2) Body weight more than 50kg and Body Mass Index(BMI) 18.0kg/m2 ~ 29.0 kg/m2 ☞ BMI(kg/m2) = Body weight (kg) / {height (m)}2 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 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 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 2) Subject with a history of pancreatitis 3) Subject with Type 1 diabetes or diabetic ketoacidosis 4) Subject with a history of gastrointestinal disorders (Crohn'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 5) Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 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) 7) Systolic blood pressure ≤100mmHg or ≥ 150mmHg, diastolic blood pressure ≤55mmHg or ≥ 95mmHg at the time of screening 8) Subject with the following results in the clinical laboratory tests - Aspartate Transaminase(AST) or Alanine Transaminase(ALT) > 2 x upper limit of normal range - Total Bilirubin > 2.0 mg/dl - CK > 2 x upper limit of normal range - eGFR < 60 mL/min/1.73m2 9) Subject who takes alcohol > 21 units/week, 1unit=10g=12.5ml of pure alcohol) or can’t stop drinking during the clinical trials 10) Subject who smokes> 10 cigarettes/day or can’t stop smoking during the clinical trials 11) Subject who have received medication involved in other clinical trials within 6 months before the first administration 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 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.) 14) Subject taking metabolizing enzyme inducers or inhibitors such as barbitals within 1 month before the first administration 15) Subject with mental illness or substance abuse 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) 17) Subject who do not agree with the approved method of contraception during the clinical trial * 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.) 18) Subject deemed inappropriate to participate in the clinical trial for clinical laboratory test results or other reasons 19) Female subject with pregnancy, serum/urine hCG Positive or breast-feeding |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Pharmacokinetics | |
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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 |
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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 |
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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 |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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