Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.
Overview[ - collapse ][ - ]
Purpose | To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose combination of mitiglinide/metformin, compared with free combination of mitiglinide and metformin in healthy male subjects. |
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Condition | Healthy |
Intervention | Drug: mitiglinide and metformin Drug: mitiglinide and metformin |
Phase | Phase 1 |
Sponsor | JW Pharmaceutical |
Responsible Party | JW Pharmaceutical |
ClinicalTrials.gov Identifier | NCT01443221 |
First Received | September 27, 2011 |
Last Updated | September 28, 2011 |
Last verified | October 2010 |
Tracking Information[ + expand ][ + ]
First Received Date | September 27, 2011 |
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Last Updated Date | September 28, 2011 |
Start Date | December 2010 |
Estimated Primary Completion Date | January 2011 |
Current Primary Outcome Measures | Compare the pharmacokinetic profiles(Cmax, AUClast) of fixed-dose combination versus free dose combination in healthy volunteers [Time Frame: Up to 36 hours postdose for each period] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Compare the pharmacokinetic profiles(tmax, t1/2, AUC0-∞) of fixed-dose combination versus free dose combination in healthy volunteers [Time Frame: Up to 36hours postdose for each period] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects. |
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Official Title | Open-label, Randomized, Single-dose, 2-way Crossover Study to Investigate Safety and Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects. |
Brief Summary | To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose combination of mitiglinide/metformin, compared with free combination of mitiglinide and metformin in healthy male subjects. |
Detailed Description | The Korean clinical practice guidelines on DM recommend that a second oral agent with a different mechanism of action be combined to the regimen when adequate glycemic control is difficult to achieve with an oral hypoglycemic agent accompanied dietary therapy. Therefore, a concurrent administration of metformin, a inhibitor of gluconeogenesis, and mitiglinide, an insulin secretagogue, could be an effective and ideal regimen for management of diabetes. |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label |
Condition | Healthy |
Intervention | Drug: mitiglinide and metformin Free combination of Mitiglinide 10mg and Metformin 500mg Drug: mitiglinide and metformin Fixed-dose combination of Mitiglinide 10mg and Metformin 500mg |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 24 |
Estimated Completion Date | January 2011 |
Estimated Primary Completion Date | January 2011 |
Eligibility Criteria | Inclusion Criteria: - Healthy males - Subject with adequate clinical laboratory test results (hematology, blood chemistry, serology, drug abuse, urinalysis etc.) - Subject with normal results in blood pressure, pulse, body temperature and ECG test - Subject with body mass index (BMI) between 18.5 kg/m2 and to 25 kg/m2 Exclusion Criteria: - Clinically significant functional disorder or acute disease - Chronic disease affecting the absorption, metabolism or excretion of drug - Any study drug administration within 90 days before the first drug administration - Use of medicine affecting drug metabolism (inhibition, induction) such as barbital, within 30 days before the first drug administration |
Gender | Male |
Ages | 20 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01443221 |
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Other Study ID Numbers | CWP-KAD-05 |
Has Data Monitoring Committee | Yes |
Information Provided By | JW Pharmaceutical |
Study Sponsor | JW Pharmaceutical |
Collaborators | Not Provided |
Investigators | Principal Investigator: Wooseong Hur, MD, PhD Samsung Medical Center |
Verification Date | October 2010 |
Locations[ + expand ][ + ]
Samsung Medical Center | Seoul, Korea, Republic of |
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