Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers

Study Overview
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Brief Summary
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Crossover study to compare the pharmacokinetic characteristics of GLH1SM sustained release tablet and Janumet XR tablet in fasting condition

Detailed Description
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2 X 2 crossover study to compare the pharmacokinetic characteristics and safety of GLH1SM sustained release 100/1000mg tablet and Janumet XR 100/1000mg tablet

Official Title
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A Randomized, Open-label, Fasting, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Combination Product: Janumet XR tablet 100/1000 mg
* Combination Product: GLH1SM tablet 100/1000 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects who, at the time of screening, are the age of older than 19 years Subjects who have BMI more than 17.5kg/m2 and less than 30.5kg/m2 and body weight more than 55kg There is no congenital disease or within 3 years of chronic diseases Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG) or clinical laboratory tests Subjects who signed and dated the informed consent form(approved by IRB) after understanding fully to hear a detailed explanation in the clinical trial Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) A subject with any history of gastrointestinal disease (e.g., Crohn's disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products A subject who has the following clinical laboratory test results Liver Function Test (AST, ALT) > two times the upper limit of the normal range History of regular alcohol consumption exceeding 210g/week(12g = 125 mL of wine, 10g = 250 mL of beer, 10g = 50 mL of hard liquor) within 6 months of Screening A subject who has participated in any other clinical trials and had medication within 3 months prior to the first administration of investigational product. (The end date of another clinical trial is based on the last day of the administration) A subject with a history of drug abuse or a positive urine drug screening for drug abuse within 1 year A subject who has taken the drugs that induce and suppress drug- metabolizing enzymes within 30 days prior to investigational product administration A smoker who consumes more than 20 cigarettes/day within 6 months A subject who has taken any ethical-the-counter drug or has taken any over- the-counter drug within 10 days before the investigational product administration A subject who has donated whole blood within 2 months or blood components within 1 month prior to the investigational product administration Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation Acute effects that may affect renal function in patients with moderate and severe renal failure (eGFR<45 mL/min/1.73m2) such as sepsis, dehydration, severe infection, cardiovascular collapse, acute myocardial infarction Acute and unstable heart failure Patients receiving intravenous administration of radiation iodine contrast media (eg, intravenous urography, venous cholangiography, angiography, computed tomography using contrast media, etc.) Patients who are known to be hypersensitive to anaphylaxis or angioedema for the drug or its components Patients with acute or chronic metabolic acidosis, including type 1 diabetes, diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis Patients with severe infectious disease or severe traumatic systemic disorder Abnormal diet that may affect absorption, distribution, metabolism and excretion of drugs Pregnant women, women who may be pregnant, breastfeeding A subject who is not eligible for the study due to reasons on the investigators' judgement

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLH1SM tablet 100/1000 mg in FDC<br>GLH1SM tablet (Sitagliptin 100 mg and Metformin 1000 mg in Fixed Dose Combination), single dose administration | Combination Product: GLH1SM tablet 100/1000 mg<br>* To administrate the GLH1SM tablet<br>* Other names: Sitagliptin and Metformin in Fixed Dose Combination;|
| Active Comparator: Janumet XR tablet 100/1000 mg in FDC<br>Janumet XR tablet (Sitagliptin 100 mg and Metformin 1000 mg in Fixed Dose Combination), single dose administration | Combination Product: Janumet XR tablet 100/1000 mg<br>* To administrate the Janumet XR tablet<br>* Other names: Sitagliptin and Metformin in Fixed Dose Combination;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt in ng·h/mL | Sitagliptin | 48 hours | 
| AUCt in ng·h/mL | Metformin | 24 hours | 
| Cmax in ng/mL | Sitagliptin | 48 hours | 
| Cmax in ng/mL | Metformin | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf in ng·h/mL | Sitagliptin, Metformin | 48 hours, 24 hours | 
| Tmax in hour | Sitagliptin, Metformin | 48 hours, 24 hours | 
| t1/2 in hour | Sitagliptin, Metformin | 48 hours, 24 hours | 
| CL/F in Liter/min/kg | Sitagliptin, Metformin | 48 hours, 24 hours | 
| Vd/F in Liter/kg | Sitagliptin, Metformin | 48 hours, 24 hours |