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

July 21, 2020 updated by: GL Pharm Tech Corporation

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

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

Study Overview

Detailed 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

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
        • Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GLH1SM tablet 100/1000 mg in FDC
GLH1SM tablet (Sitagliptin 100 mg and Metformin 1000 mg in Fixed Dose Combination), single dose administration
To administrate the GLH1SM tablet
Other Names:
  • Sitagliptin and Metformin in Fixed Dose Combination
Active Comparator: Janumet XR tablet 100/1000 mg in FDC
Janumet XR tablet (Sitagliptin 100 mg and Metformin 1000 mg in Fixed Dose Combination), single dose administration
To administrate the Janumet XR tablet
Other Names:
  • Sitagliptin and Metformin in Fixed Dose Combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCt in ng·h/mL
Time Frame: 24 hours
Metformin
24 hours
Cmax in ng/mL
Time Frame: 24 hours
Metformin
24 hours

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 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
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
Vital signs in blood pressure
Time Frame: 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
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
Vital signs in pulse
Time Frame: 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
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
Vital signs in temperature
Time Frame: 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
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
Physical examinations in weight
Time Frame: 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
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
Physical examinations in height
Time Frame: 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
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
Clinical laboratories in blood sample
Time Frame: 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
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
12-lead ECG in clinical significance
Time Frame: Screening(between 2 day and 28 day before IP administration), and one day between 3 day and 7 day after last blood sampling
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2019

Primary Completion (Actual)

September 11, 2019

Study Completion (Actual)

October 23, 2019

Study Registration Dates

First Submitted

April 23, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 25, 2019

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

September 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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