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

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ClinicalTrials.gov Identifier: NCT02056600
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: gemigliptin and metformin HCl extended release Drug: gemigliptin/metformin HCl sustained release Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : March 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. AUClast [ Time Frame: up to 48h post-dose ]
    To evaluate AUClast of gemigliptin and metformin

  2. Cmax [ Time Frame: up to 48h post-dose ]
    To evaluate Cmax of gemigliptin and metformin



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056600


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT02056600     History of Changes
Other Study ID Numbers: LG-DMCL004
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: May 8, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
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Metformin
Hypoglycemic Agents
Physiological Effects of Drugs