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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionHealthy
InterventionDrug: gemigliptin and metformin HCl extended release
Drug: gemigliptin/metformin HCl sustained release
PhasePhase 1
SponsorLG Life Sciences
Responsible PartyLG Life Sciences
ClinicalTrials.gov IdentifierNCT02056600
First ReceivedFebruary 5, 2014
Last UpdatedFebruary 5, 2014
Last verifiedFebruary 2014

Tracking Information[ + expand ][ + ]

First Received DateFebruary 5, 2014
Last Updated DateFebruary 5, 2014
Start DateMarch 2014
Estimated Primary Completion DateMay 2014
Current Primary Outcome Measures
  • AUClast [Time Frame: up to 48h post-dose] [Designated as safety issue: No]To evaluate AUClast of gemigliptin and metformin
  • Cmax [Time Frame: up to 48h post-dose] [Designated as safety issue: No]To evaluate Cmax of gemigliptin and metformin
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleBE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone.
Official TitleA 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
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
ConditionHealthy
InterventionDrug: gemigliptin and metformin HCl extended release
Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day
Drug: gemigliptin/metformin HCl sustained release
Administration of combination of gemigliptin 50mg/metformin HCl sustained release 1000mg, for 1day.
Study Arm (s)
  • Experimental: G+M
    Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg
  • Experimental: C
    Combination of gemigliptin50mg/metformin HCl sustained release 1000mg

Recruitment Information[ + expand ][ + ]

Recruitment StatusNot yet recruiting
Estimated Enrollment24
Estimated Completion DateMay 2014
Estimated Primary Completion DateApril 2014
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
GenderMale
Ages20 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsContact: JongHyuk Jung, Mr.
82-2-6924-3120
jhjung@lgls.com
Location CountriesKorea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number NCT02056600
Other Study ID NumbersLG-DMCL004
Has Data Monitoring CommitteeNo
Information Provided ByLG Life Sciences
Study SponsorLG Life Sciences
CollaboratorsNot Provided
Investigators Not Provided
Verification DateFebruary 2014

Locations[ + expand ][ + ]

Asan Medical Center
Seoul, Korea, Republic of
Contact: Kyun-Seop Bae, M.D., Ph D.
Not yet recruiting