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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927170
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
GL Pharm Tech Corporation

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

Condition or disease Intervention/treatment Phase
Healthy Combination Product: Janumet XR tablet 100/1000 mg Combination Product: GLH1SM tablet 100/1000 mg Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Fed, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers
Actual Study Start Date : May 2, 2019
Actual Primary Completion Date : September 11, 2019
Actual Study Completion Date : October 23, 2019

Resource links provided by the National Library of Medicine


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
Combination Product: GLH1SM tablet 100/1000 mg
To administrate the GLH1SM tablet
Other Name: 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
Combination Product: Janumet XR tablet 100/1000 mg
To administrate the Janumet XR tablet
Other Name: Sitagliptin and Metformin in Fixed Dose Combination




Primary Outcome Measures :
  1. AUCt in ng·h/mL [ Time Frame: 24 hours ]
    Metformin

  2. Cmax in ng/mL [ Time Frame: 24 hours ]
    Metformin


Secondary Outcome Measures :
  1. AUCinf in ng·h/mL [ Time Frame: 24 hours ]
    Metformin

  2. Tmax in hour [ Time Frame: 24 hours ]
    Metformin

  3. t1/2 in hour [ Time Frame: 24 hours ]
    Metformin

  4. CL/F in Liter/min/kg [ Time Frame: 24 hours ]
    Metformin

  5. Vd/F in Liter/kg [ Time Frame: 24 hours ]
    Metformin


Other Outcome Measures:
  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927170


Locations
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Korea, Republic of
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
Sponsors and Collaborators
GL Pharm Tech Corporation
Investigators
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Principal Investigator: Kyungho Jang, MD, Ph.D Chonbuk National University Hospital
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Responsible Party: GL Pharm Tech Corporation
ClinicalTrials.gov Identifier: NCT03927170    
Other Study ID Numbers: GLH1SM-102
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action