BIOAVAILABILITY OF Glimepiride/Extended Release Metformin (GLI/METXR): High Fat Diet Study
Overview[ - collapse ][ - ]
| Purpose | Objective: The purpose of this study is to evaluate the effect of food intake in bioavailability (BA) of the combination Glimepiride/ extended release Metformin GLI/METXR (4/850mg) in healthy Mexican volunteers. Methods: A prospective, longitudinal, open label, non randomized study, was performed. A single oral dose of GLI/METXR (4/850 mg)was administered to 24 health Mexican volunteers 30 min after a high fat meal. Blood samples were collected before the administration and 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6.7, 8, 10, 12, 16, 20, 24 and 30 hours post-administration. Plasma concentration of the drug was measured by using HPLC. Plasma concentration of botk drugs were measured using high-performance liquid chromatography (HPLC). Plasma concentration time curves were plotted for each volunteers, and pharmacokinetic parameters (PK) were calculated. Adverse events were determined using clinical and laboratory test results throughout the study. |
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| Condition | Healthy |
| Intervention | Drug: Glimepiride/extended release Metformin |
| Phase | Phase 1 |
| Sponsor | Laboratorios Silanes S.A. de C.V. |
| Responsible Party | Laboratorios Silanes S.A. de C.V. |
| ClinicalTrials.gov Identifier | NCT01437813 |
| First Received | September 19, 2011 |
| Last Updated | September 20, 2011 |
| Last verified | January 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 19, 2011 |
|---|---|
| Last Updated Date | September 20, 2011 |
| Start Date | January 2011 |
| Estimated Primary Completion Date | March 2011 |
| Current Primary Outcome Measures | Pharmacokinetic Profile [Time Frame: Predose,0.25, 0.5, 0.75, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16,20, 24 y 30 hours post-dose] [Designated as safety issue: No]Cmax, Area Under Curve, Tmax |
| Current Secondary Outcome Measures | Adverse Events [Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16,20, 24 y 30 hours post-dose] [Designated as safety issue: Yes]Any change in health or undesirable experience in volunteers related or unrelated with the experimental drug. Adverse events were determined using clinical and laboratory test results, throughout the study. |
Descriptive Information[ + expand ][ + ]
| Brief Title | BIOAVAILABILITY OF Glimepiride/Extended Release Metformin (GLI/METXR): High Fat Diet Study |
|---|---|
| Official Title | Bioavailability of Glimepiride/Extended Release Metformin (4/850 mg) After a High Fat Diet, in Healthy Mexican Volunteers |
| Brief Summary | Objective: The purpose of this study is to evaluate the effect of food intake in bioavailability (BA) of the combination Glimepiride/ extended release Metformin GLI/METXR (4/850mg) in healthy Mexican volunteers. Methods: A prospective, longitudinal, open label, non randomized study, was performed. A single oral dose of GLI/METXR (4/850 mg)was administered to 24 health Mexican volunteers 30 min after a high fat meal. Blood samples were collected before the administration and 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6.7, 8, 10, 12, 16, 20, 24 and 30 hours post-administration. Plasma concentration of the drug was measured by using HPLC. Plasma concentration of botk drugs were measured using high-performance liquid chromatography (HPLC). Plasma concentration time curves were plotted for each volunteers, and pharmacokinetic parameters (PK) were calculated. Adverse events were determined using clinical and laboratory test results throughout the study. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Healthy |
| Intervention | Drug: Glimepiride/extended release Metformin One tablet of Glimepiride/metformin extended release (4/850 mg) was administered as a single oral dose. Patients received a high fat diet 30 min before administration. Other Names: GLIMETXR |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 24 |
| Estimated Completion Date | March 2011 |
| Estimated Primary Completion Date | January 2011 |
| Eligibility Criteria | Inclusion Criteria: - Healthy Mexican volunteers, considered healthy according to standard screening assessments - Aged between 18 and 50 years old - Body mass index (BMI) was 18 to 27.5 Exclusion Criteria: - Those with a history or evidence of cardiovascular, renal, hepatic, gastrointestinal, neurologic, muscular, metabolic, or hematologic abnormality - Any acute or chronic disease - Any drug allergy and female volunteers positive to urinary pregnancy test or breastfeeding |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Mexico |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01437813 |
|---|---|
| Other Study ID Numbers | GLMT13-SIL |
| 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 | Instituto Mexicano del Seguro Social |
| Investigators | Principal Investigator: Yamanqui Ibañez, Dr. INVESTIGACIÓN FARMACOLÓGICA Y BIOFARMACEUTICA. |
| Verification Date | January 2011 |
Locations[ + expand ][ + ]
| Investigación Farmacológica Y Biofarmaceutica, S.A. de C.V. | México, Mexico, 14610 |
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