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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03927170

Recruitment Status Completed

First Posted April 25, 2019

Last update posted July 23, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Healthy
  • Intervention/Treatment: Combination Product: Janumet XR tablet 100/1000 mg
    Combination Product: GLH1SM tablet 100/1000 mg
  • Phase: 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

Study Design
  • Study Type: Interventional
  • 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 2019
  • Actual Primary Completion Date: September 2019
  • Actual Study Completion Date: October 2019
Arms and interventions
Arm Intervention/treatment
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
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
Outcome Measures
  • 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. 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
  • 2. 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
  • 3. 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
  • 4. 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)
  • 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
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

GL Pharm Tech Corporation

Investigators

Principal Investigator: Kyungho Jang, MD, Ph.D Chonbuk National University Hospital

More Information
  • Responsible Party: GL Pharm Tech Corporation
  • ClinicalTrials.gov Identifier: NCT03927170 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No