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Completed

NCT Number: NCT02056600

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

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.

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gemigliptin and metformin HCl extended release

Drug

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

gemigliptin/metformin HCl sustained release

Drug

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 6, 2014
Registry last updated
May 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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