A Study to Evaluate Safety and Pharmacokinetic Characteristics after Administration of the SJP003 in Healthy Male Volunteers

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0004019
• Lead Sponsor: Samjin Pharmaceutical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

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

Inclusion Criteria

1) Healthy adult male volunteers whose age is at least 19 years old and under 45 years of age at screening
2) Those with a body weight greater than 50.0 kg and a body mass index (BMI) greater than 18.0 kg / m2 and less than 30.0 kg / m2
? BMI (kg / m 2) = body weight (kg) / {height (m)} 2
3) Those who do not have congenital or chronic disease requiring treatment and do not have pathologic symptoms or findings as a result of medical examination
4) Those who have been found to be suitable for the clinical trial subject by clinical laboratory tests, such as serum test, hematology test, blood chemistry test, urine test, urine drug test etc, and vital signs , physical examination, 12-lead ECG etc., set and performed according to the characteristics of medicines during screening
5) Those who has agreed to voluntarily participate in the clinical trial and to observe the subjects' precautions during the clinical trial period after hearing and understanding the details of the clinical trial

Exclusion Criteria

1) Those with clinically significant current or previous history of liver, kidney, nervous system, respiratory system, endocrine system, blood or tumor, urinary, cardiovascular, musculoskeletal or mental illness. In addition, those who have the following symptoms or history
? type 1 diabetes or diabetic ketoacidosis
? diabetic pre-coma
? renal (acute kidney damage and renal dysfunction) and liver dysfunction
? heart failure
? Those at high risk of bleeding, including severe trauma and surgery
2) Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
3) Those 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 drugs
4) Those with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs including dapagliflozin and other drugs (including fibrates, ketoprofen, aspirin, antibiotics, etc)
5) At the time of screening, Those whose results of 12-lead ECG show clinically significant findings including the following findings
? QTc > 450 msec
? PR interval > 200 msec
? QRS duration > 120 msec
6) When screening, Thowe whose results fo clinical laboratory tests show the following results
? AST, ALT, ALP, ?-GTP and bilirubin total exceeding twice the upper limit of normal range in clinical laboratory tests for liver function evaluation
? If serum creatinine levels exceed the normal range or eGFR calculated by the Modification of Diet in Renal Disease (MDRD) is less than 60 mL / min / 1.73 m2
7) If you have a history of drug abuse or positive urine drug testing
8) At the time of screening, after resting for more than 3 minutes, at the vital sign measured in a sitting position, the systolic blood pressure = 150 mmHg or =90 mmHg or the diastolic blood pressure =100 mmHg or =60 mmHg, pulse = 40 times / min or = 100 times / min
9) Abnormal diets that can affect the absorption, distribution, metabolism and excretion of drugs or food supplements that can affect drug metabolism
10) Within 2 weeks before the first dosing day, those taking any ETC or herbal medicine, including cyclosporine, or within a week, those taking any OTC or vitamin, that may affect the characteristics of the clinical trial drug (However, if the drug does not affect the pharmacokinetic properties of the clinical trial drug, it may be taken at the discretion of the tester.)
11) Those taking a drug-metabolizing enzyme inducing and inhibiting drug such as barbiturate drugs within 1 month before the first dosing day
12) Those who have received medication within 3 months before the first dosing day by participating in other drug clinical trials or bioequivalence test (However, the criteria for the termination of participation in other clinical trials shall be based on the last day of administration, and the next day shall be calculated as 1 day.)
13) Those who donated whole blood within 2 months before the first dosing day or component blood within 1 month, or have received blood transfusions within 1 month
14) Those drinking persistently within 6 months before the first dosing day(over 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or who can't quit from 48 hours before the first dose to PSV
ex. 1 cup of Beer (5 %) (250 mL) = 10 g
1 cup of Soju (20 %) (50 mL) = 8 g

Study & Design

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

Primary Outcome Measures

Name	Time	Method
AUC0-t;Cmax

Secondary Outcome Measures

Name	Time	Method
AUCinf