BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone
A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone in Healthy Male Volunteers
1 other identifier
interventional
29
1 country
1
Brief Summary
This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component administered alone in healthy male volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Dec 2014
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2012
CompletedFirst Posted
Study publicly available on registry
May 10, 2012
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFebruary 3, 2015
February 1, 2015
1 month
May 8, 2012
February 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
AUClast, Cmax
To evaluate AUClast and Cmax of gemigliptin and metformin
up to 48h post-dose
Secondary Outcomes (1)
AUCinf, Tmax, t1/2, CL/F, metabolic ratio
up to 48h post-dose
Study Arms (2)
G+M
EXPERIMENTALCoadministration of gemigliptin 50mg and metformin HCl extended release 500mg
C
EXPERIMENTALCombination of gemigliptin50mg/metformin HCl extended release 500mg
Interventions
Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg, for 1 day
Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.
Eligibility Criteria
You may qualify if:
- Age between 20 to 45, healthy male subjects(at screening)
- Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
- FPG 70-125mg/dL glucose level(at screening)
- Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
You may not qualify if:
- Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
- Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
- Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
- Subject who already participated in other trials in 2months
- Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
- Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Life Scienceslead
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Kyung-sang Yu, M.D,Ph.D
Seoul national univ. hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2012
First Posted
May 10, 2012
Study Start
December 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
February 3, 2015
Record last verified: 2015-02