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

NCT ID: NCT02056600

Last Updated: 2014-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-05-31

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

G+M

Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg

Group Type: EXPERIMENTAL

gemigliptin and metformin HCl extended release

Intervention Type: DRUG

Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day

C

Combination of gemigliptin50mg/metformin HCl sustained release 1000mg

Group Type: EXPERIMENTAL

gemigliptin/metformin HCl sustained release

Intervention Type: DRUG

Administration of combination of gemigliptin 50mg/metformin HCl sustained release 1000mg, for 1day.

Interventions

gemigliptin and metformin HCl extended release

Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day

Intervention Type: DRUG

gemigliptin/metformin HCl sustained release

Administration of combination of gemigliptin 50mg/metformin HCl sustained release 1000mg, for 1day.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

LG Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 30288156 (View on PubMed)

Other Identifiers

LG-DMCL004

Identifier Type: -

Identifier Source: org_study_id