Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers(Fed)

GL Pharm Tech

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Combination Product: GLH1SM tablet 100/1000 mg

Combination Product: Janumet XR tablet 100/1000 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03927170

GLH1SM-102

Details and patient eligibility

About

Crossover study to compare the pharmacokinetic characteristics of GLH1SM sustained release tablet and Janumet XR tablet in fed condition

Full description

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

Enrollment

25 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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