BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone
Overview[ - collapse ][ - ]
| Purpose | This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of the combinations of gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component administered alone in healthy male volunteers. |
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| Condition | Healthy |
| Intervention | Drug: gemigliptin and metformin HCl extended release Drug: gemigliptin/metformin HCl extended release |
| Phase | Phase 1 |
| Sponsor | LG Life Sciences |
| Responsible Party | LG Life Sciences |
| ClinicalTrials.gov Identifier | NCT01595880 |
| First Received | May 8, 2012 |
| Last Updated | November 16, 2012 |
| Last verified | November 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 8, 2012 |
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| Last Updated Date | November 16, 2012 |
| Start Date | December 2012 |
| Estimated Primary Completion Date | January 2013 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures | AUEC [Time Frame: up to 48h post-dose] [Designated as safety issue: No]This parameter is been used to measure pharmarcodynamic characters of gemigliptin and metformin, the supression rate of DPP4 activity. |
Descriptive Information[ + expand ][ + ]
| Brief Title | BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone |
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| Official Title | A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone in Healthy Male Volunteers |
| Brief Summary | This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of the combinations of gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component administered alone in healthy male volunteers. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Healthy |
| Intervention | Drug: gemigliptin and metformin HCl extended release Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg, for 1 day Drug: gemigliptin/metformin HCl extended release Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
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| Estimated Enrollment | 28 |
| Estimated Completion Date | January 2013 |
| Estimated Primary Completion Date | December 2012 |
| Eligibility Criteria | Inclusion Criteria: - 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. Exclusion Criteria: - 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) |
| Gender | Male |
| Ages | 20 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Contact: Jong Hyuk Jung, MS 82-2-6924-3120 jiyungbori@lgls.com |
| Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01595880 |
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| Other Study ID Numbers | LG-DMCL001 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | LG Life Sciences |
| Study Sponsor | LG Life Sciences |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Kyung-sang Yu, M.D,Ph.D Seoul national univ. hospital |
| Verification Date | November 2012 |
Locations[ + expand ][ + ]
| Seoul National University Hospital | Seoul, Korea, Republic of, 110-744 Contact: Dong Seong Shin, MD | 82-2-2072-4082 | joy9834@snu.ac.krNot yet recruiting |
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