A Pharmacokinetic Evaluation of Metformin in Relation to the Polymorphism A270S in Healthy Caucasian Volunteers
Overview[ - collapse ][ - ]
| Purpose | The aim of the study is to evaluate the pharmacokinetics of metformin in healthy Caucasians volunteers with and without the polymorphism A270S in OCT2,thus the study hypothesis is that renal clearance of metformin is affected in Caucasian with the known single nucleotide polymorphisms A270S in OCT2. |
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| Condition | Metformin Organic Cation Transporter 2 Polymorphism,Single Nucleotide |
| Intervention | Drug: Metformin |
| Phase | Phase 4 |
| Sponsor | University of Southern Denmark |
| Responsible Party | University of Southern Denmark |
| ClinicalTrials.gov Identifier | NCT01237522 |
| First Received | November 8, 2010 |
| Last Updated | December 28, 2010 |
| Last verified | June 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 8, 2010 |
|---|---|
| Last Updated Date | December 28, 2010 |
| Start Date | August 2010 |
| Estimated Primary Completion Date | December 2010 |
| Current Primary Outcome Measures | Renal clearance of metformin [Time Frame: 24 Hours] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Pharmacokinetic Evaluation of Metformin in Relation to the Polymorphism A270S in Healthy Caucasian Volunteers |
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| Official Title | A Pharmacokinetic Evaluation of Metformin in Relation to the Polymorphism A270S in Healthy Caucasian Volunteers. |
| Brief Summary | The aim of the study is to evaluate the pharmacokinetics of metformin in healthy Caucasians volunteers with and without the polymorphism A270S in OCT2,thus the study hypothesis is that renal clearance of metformin is affected in Caucasian with the known single nucleotide polymorphisms A270S in OCT2. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research |
| Condition |
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| Intervention | Drug: Metformin A single dose study with one tablet of metformin 500 mg, time frame 24 hours Other Names: Orabet |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 50 |
| Estimated Completion Date | December 2010 |
| Estimated Primary Completion Date | December 2010 |
| Eligibility Criteria | Inclusion Criteria: - Healthy volunteers - Written consent - rs316019 genotyped - Age 18-65 years old Exclusion Criteria: - Daily medication - Alcohol abuse - Pregnancy - Breastfeeding |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Denmark |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01237522 |
|---|---|
| Other Study ID Numbers | AKF- 377 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | University of Southern Denmark |
| Study Sponsor | University of Southern Denmark |
| Collaborators | Not Provided |
| Investigators | Study Chair: Kim Broesen, Professor University of Southern Denmark |
| Verification Date | June 2010 |
Locations[ + expand ][ + ]
| Institute of Public Health, Clinical Pharmacology, University of Southern Denmark | Odense, Denmark, 5000 |
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