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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927170
• Other study ID #: GLH1SM-102
• Status: Completed
• Phase: Phase 1
• Start date: May 2, 2019
• Est. completion date: October 23, 2019

Study information

• Verified date: September 2019
• Source: GL Pharm Tech Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 23, 2019
• Est. primary completion date: September 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Combination Product:
• Janumet XR tablet 100/1000 mg
To administrate the Janumet XR tablet
• GLH1SM tablet 100/1000 mg
To administrate the GLH1SM tablet

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
GL Pharm Tech Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	To 28 days after last IP administration	1 day before IP administration, 1 day, 2 day, 3 day of each period, and one day between 3 day and 7 day after last blood sampling
Other	Vital signs in blood pressure	Blood pressure(SBP, DBP)	Screening(between 2 day and 28 day before IP administration), 1 day and 3 day of each period, and one day between 3 day and 7 day after last blood sampling
Other	Vital signs in pulse	Pulse rate	Screening(between 2 day and 28 day before IP administration), 1 day and 3 day of each period, and one day between 3 day and 7 day after last blood sampling
Other	Vital signs in temperature	eardrum	Screening(between 2 day and 28 day before IP administration), 1 day and 3 day of each period, and one day between 3 day and 7 day after last blood sampling
Other	Physical examinations in weight	Weight in kilograms	Screening(between 2 day and 28 day before IP administration), 1 day before IP administration, 1 day, 2 day, 3 day of each period, and one day between 3 day and 7 day after last blood sampling
Other	Physical examinations in height	Height in meters	Screening(between 2 day and 28 day before IP administration), 1 day before IP administration, 1 day, 2 day, 3 day of each period, and one day between 3 day and 7 day after last blood sampling
Other	Clinical laboratories in blood sample	Normal blood chemistry, Type B hepatitis, Type C hepatitis, HIV, and Syphilis	Screening(between 2 day and 28 day before IP administration), 1 day before IP administration, and 3 day of each period, and one day between 3 day and 7 day after last blood sampling
Other	12-lead ECG in clinical significance	QRS complex	Screening(between 2 day and 28 day before IP administration), and one day between 3 day and 7 day after last blood sampling
Primary	AUCt in ng·h/mL	Metformin	24 hours
Primary	Cmax in ng/mL	Metformin	24 hours
Secondary	AUCinf in ng·h/mL	Metformin	24 hours
Secondary	Tmax in hour	Metformin	24 hours
Secondary	t1/2 in hour	Metformin	24 hours
Secondary	CL/F in Liter/min/kg	Metformin	24 hours
Secondary	Vd/F in Liter/kg	Metformin	24 hours