Phase I clinical trial to compare the pharmacokinetics and safety of RDN18002 with co-administration of sitagliptin and empagliflozin in healthy adult volunteers

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0004290
• Lead Sponsor: Huons

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUCt of sitagliptin and empagliflozin;Cmax of of sitagliptin and empagliflozin

Secondary Outcome Measures

Name	Time	Method
AUCinf of of sitagliptin and empagliflozin;Tmax of of sitagliptin and empagliflozin;T1/2 of of sitagliptin and empagliflozin