BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone.

A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/1000mg in Comparison to Each Component Gemigliptin 50mg and Metformin HCl Extended Release 1000mg Administered in Healthy Male Volunteers

This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered in healthy male volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: gemigliptin and metformin HCl extended release; Drug: gemigliptin/metformin HCl sustained release

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male adults at age between 20 to 45 at the time of the screening
• ThoseSubjects whose BMI measurement at screening visit is between 18 and 27 kg/m2
• Subjects with fasting plasma glucose (FPG) of 70-125 mg/dL at screening visit
• Subject who has voluntarily decided to participate in this clinical trial and onsented in writing

Exclusion Criteria:

• Subjects who have a past or present clinically significant disease such as hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, neurological, hemato-oncological, or cardiovascular disorder
• Subjects who have a past history of gastrointestinal disease (e.g. Crohn's disease, ulcer, etc.) or surgery (however, simple appendectomy and hernioplasty are not included) that can affect the absorption of drugs
• Subjects with a medical history of allergic reaction to other drugs including the investigational products or clinically significant hypersensitivity reaction
• Subjects who have a history of drug abuse
• Subjects who have shown positive reaction to drugs that may be abused from a urine drug screening
• Subjects who took other investigational product in other trials within 90 days before the first administration of this investigational product
• Subjects who had whole blood donation within 60 days or component blood donation within 30 days before the first administration of the investigational product, or transfusion within 30 days before the first administration
• Subjects who have taken a drug which is expected to have an effect on the clinical trial within 14 days before the date of the first administration of the investigational product or have had any food that is expected to have an effect on the clinical trial within 7 days (e.g. drinks containing caffeine, grapefruit juice, etc.)
• Subjects who have had alcohol containing drinks 3 times or more per week within one month before the screening visit or cannot abstain from drinking after completing the informed consent form for the participation in the study to the end of the clinical trial
• Subjects who have smoker more than 10 cigarettes per day within the recent one month at the screening visit or cannot refrain from smoking the clinical trial period
• In the vital signs measured in sitting position at the screening visit, subjects who have showed a systolic blood pressure of < 90 mmHg or > 145 mmHg, a diastolic blood pressure of > 95 mmHg or < 60 mmHg) , or a pulse rate of > 110 bpm or < 40 bpm
• Subjects who showed the following findings in the tests conducted during the screening period:
• In excess of 1.5 times the upper normal limit (UNL) in hepatic enzyme (AST and ALT) values
• The creatinine clearance calculated by Cockcroft-Gault equation is 80 mL/min or less
• Positive result in serum test (hepatitis type B test, hepatitis type C test, Human Immunodeficiency Virus (HIV) test, syphilis test)
• QTc > 450 msec in ECG or a clinically significant abnormal rhythm
• Subjects who are considered to be unsuitable in conducting the clinical trial for other reason at the principal investigator's discretionary judgment

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G+M; Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg	Drug: gemigliptin and metformin HCl extended release; Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day
Experimental: C; Combination of gemigliptin50mg/metformin HCl sustained release 1000mg	Drug: gemigliptin/metformin HCl sustained release; Administration of combination of gemigliptin 50mg/metformin HCl sustained release 1000mg, for 1day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUClast	To evaluate AUClast of gemigliptin and metformin	up to 48h post-dose
Cmax	To evaluate Cmax of gemigliptin and metformin	up to 48h post-dose

Collaborators and Investigators

• Sponsor: LG Life Sciences

Publications and helpful links

General Publications

• Cho YS, Lee SH, Lim HS, Bae KS. Pharmacokinetic Equivalence of the High Dose Strength Fixed-Dose Combination Tablet of Gemigliptin/Metformin Sustained Release (SR) and Individual Component Gemigliptin and Metformin XR Tablets in Healthy Subjects. J Korean Med Sci. 2018 Sep 5;33(41):e258. doi: 10.3346/jkms.2018.33.e258. eCollection 2018 Oct 8.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: February 5, 2014
• First Submitted That Met QC Criteria: February 5, 2014
• First Posted (Estimate): February 6, 2014

Study Record Updates

• Last Update Posted (Estimate): May 8, 2014
• Last Update Submitted That Met QC Criteria: May 7, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: LG-DMCL004