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CompletedNCT03927170Updated Jul 23, 2020

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

A Phase 1 interventional study of Janumet XR tablet 100/1000 mg and GLH1SM tablet 100/1000 mg in Healthy, sponsored by GL Pharm Tech Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-23.

Sponsored by GL Pharm Tech Corporation · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

GL Pharm Tech Corporation is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Combination productJanumet XR tablet 100/1000 mg

    To administrate the Janumet XR tablet

    Also known as: Sitagliptin and Metformin in Fixed Dose Combination

  • Combination productGLH1SM tablet 100/1000 mg

    To administrate the GLH1SM tablet

    Also known as: Sitagliptin and Metformin in Fixed Dose Combination

06

What researchers measure

Primary outcomes

  1. AUCt in ng·h/mL

    Metformin

    Time frame: 24 hours

  2. Cmax in ng/mL

    Metformin

    Time frame: 24 hours

Secondary outcomes

  1. AUCinf in ng·h/mL

    Metformin

    Time frame: 24 hours

  2. Tmax in hour

    Metformin

    Time frame: 24 hours

  3. t1/2 in hour

    Metformin

    Time frame: 24 hours

  4. CL/F in Liter/min/kg

    Metformin

    Time frame: 24 hours

  5. Vd/F in Liter/kg

    Metformin

    Time frame: 24 hours

Other outcomes

  1. Adverse events

    To 28 days after last IP administration

    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

  2. Vital signs in blood pressure

    Blood pressure(SBP, DBP)

    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

  3. Vital signs in pulse

    Pulse rate

    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

  4. Vital signs in temperature

    eardrum

    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

  5. Physical examinations in weight

    Weight in kilograms

    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

  6. Physical examinations in height

    Height in meters

    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

  7. Clinical laboratories in blood sample

    Normal blood chemistry, Type B hepatitis, Type C hepatitis, HIV, and Syphilis

    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

  8. 12-lead ECG in clinical significance

    QRS complex

    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

07

Study locations

1 site
  • Chonbuk National University Hospital
    Jeonju, Jeollabuk-do 54907, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03927170
Lead sponsor
GL Pharm Tech Corporation
Responsible party
Sponsor
First posted
Apr 25, 2019
Start date
May 2, 2019
Primary completion
Sep 11, 2019
Completion
Oct 23, 2019
Last update
Jul 23, 2020

Study contacts

Kyungho Jang, MD, Ph.D
principal investigator · Chonbuk National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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