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

NCT03927170 | Completed Phase 1

• 1 other identifier: GLH1SM-102
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCt in ng·h/mL

  Metformin

  24 hours

• Cmax in ng/mL

  Metformin

  24 hours

Secondary Outcomes (5)

• AUCinf in ng·h/mL

  24 hours

• Tmax in hour

  24 hours

• t1/2 in hour

  24 hours

• CL/F in Liter/min/kg

  24 hours

• Vd/F in Liter/kg

  24 hours

Other Outcomes (8)

• Adverse events

  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

  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

  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

Study Arms (2)

GLH1SM tablet 100/1000 mg in FDC

EXPERIMENTAL

GLH1SM tablet (Sitagliptin 100 mg and Metformin 1000 mg in Fixed Dose Combination), single dose administration

Combination Product: GLH1SM tablet 100/1000 mg

Janumet XR tablet 100/1000 mg in FDC

ACTIVE COMPARATOR

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

Janumet XR tablet 100/1000 mg COMBINATION_PRODUCT

To administrate the Janumet XR tablet

Also known as: Sitagliptin and Metformin in Fixed Dose Combination

Janumet XR tablet 100/1000 mg in FDC

GLH1SM tablet 100/1000 mg COMBINATION_PRODUCT

To administrate the GLH1SM tablet

Also known as: Sitagliptin and Metformin in Fixed Dose Combination

GLH1SM tablet 100/1000 mg in FDC

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GL Pharm Tech Corporation: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

MeSH Terms

Interventions

Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination; Sitagliptin Phosphate; Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Kyungho Jang, MD, Ph.D

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: May 2, 2019
• Primary Completion: September 11, 2019
• Study Completion: October 23, 2019
• Last Updated: July 23, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)