Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male Subjects
Overview[ - collapse ][ - ]
Purpose | This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and Metformin IR 1000 mg after oral administration in healthy male volunteers. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: DA-1229 Drug: metformin Drug: DA-1229 + metformin |
Phase | Phase 1 |
Sponsor | Dong-A Pharmaceutical Co., Ltd. |
Responsible Party | Dong-A Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier | NCT01941199 |
First Received | September 9, 2013 |
Last Updated | November 25, 2013 |
Last verified | November 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | September 9, 2013 |
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Last Updated Date | November 25, 2013 |
Start Date | July 2013 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male Subjects |
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Official Title | A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 5 mg and Metformin IR 1000 mg After Oral Administration in Healthy Male Volunteers |
Brief Summary | This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and Metformin IR 1000 mg after oral administration in healthy male volunteers. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: DA-1229 Drug: metformin Drug: DA-1229 + metformin |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 36 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | November 2013 |
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(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded) - Subject who had drug(Aspirin, antibiotics) hypersensitivity reaction - Subject who already participated in other trials in 2 months - Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion in 1 months currently. |
Gender | Male |
Ages | 20 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01941199 |
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Other Study ID Numbers | DA1229_DIM_I |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Dong-A Pharmaceutical Co., Ltd. |
Study Sponsor | Dong-A Pharmaceutical Co., Ltd. |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | November 2013 |
Locations[ + expand ][ + ]
Clinical Trial Center, Seoul National University Hospital | Seoul, Korea, Republic of, 110-744 |
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