Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER)
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of an extended release metformin compared with an immediate release metformin in healthy subjects. |
|---|---|
| Condition | Healthy |
| Intervention | Drug: metformin ER Drug: metformin |
| Phase | Phase 1 |
| Sponsor | Laboratorios Silanes S.A. de C.V. |
| Responsible Party | Laboratorios Silanes S.A. de C.V. |
| ClinicalTrials.gov Identifier | NCT00941239 |
| First Received | July 15, 2009 |
| Last Updated | July 16, 2009 |
| Last verified | July 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 15, 2009 |
|---|---|
| Last Updated Date | July 16, 2009 |
| Start Date | January 2007 |
| Estimated Primary Completion Date | February 2007 |
| Current Primary Outcome Measures | Plasmatic drug concentration [Time Frame: 48 hours (7.5, 15,30,45,60,75,90,120,150,180,205,240,360,480,600,720,1440,2880 min and days : 3,5,7,14,21,28,30,35)] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER) |
|---|---|
| Official Title | Gastric Tolerability and Pharmacokinetics of an Extended Release Metformin and an Immediate Release Metformin |
| Brief Summary | The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of an extended release metformin compared with an immediate release metformin in healthy subjects. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Healthy |
| Intervention | Drug: metformin ER 850mg daily for 30 days Other Names: predial plusDrug: metformin 850 mg daily for 30 days |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 24 |
| Estimated Completion Date | February 2007 |
| Estimated Primary Completion Date | February 2007 |
| Eligibility Criteria | Inclusion Criteria: - Mexican healthy subjects with normal clinical laboratory test results and imaging (hematology, blood chemistry, urine test, VDRL, Hepatitis B, VIH, chest radiography and electrocardiogram) Exclusion Criteria: - Familiar or personal history of diabetes - History of drug or alcohol abuse within the 2 years prior to the study - A smoking habit greater than 10 cigarettes per day - History of allergy to the study drugs - Intercurrent disease - Intercurrent treatment with any drug |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Mexico |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00941239 |
|---|---|
| Other Study ID Numbers | Met-LP 1007/06 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Laboratorios Silanes S.A. de C.V. |
| Study Sponsor | Laboratorios Silanes S.A. de C.V. |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Oscar Torres, Ph D UANL, Pharmacology and toxicology departmentStudy Director: Jorge A Gonzalez Laboratorios Silanes S.A. de C.V. |
| Verification Date | July 2009 |
Locations[ + expand ][ + ]
| Pharmacology and toxicology department, UANL | Monterrey, Nuevo León, Mexico, 64460 |
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