BIOAVAILABILITY OF Glimepiride/Extended Release Metformin (GLI/METXR): High Fat Diet Study (GLMT13)
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|ClinicalTrials.gov Identifier: NCT01437813|
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : September 21, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Glimepiride/extended release Metformin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bioavailability of Glimepiride/Extended Release Metformin (4/850 mg) After a High Fat Diet, in Healthy Mexican Volunteers|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||March 2011|
- 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 Name: GLIMETXR
- 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 ]Cmax, Area Under Curve, Tmax
- 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 ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437813
|Investigación Farmacológica Y Biofarmaceutica, S.A. de C.V.|
|México, Mexico, 14610|
|Principal Investigator:||Yamanqui Ibañez, Dr.||INVESTIGACIÓN FARMACOLÓGICA Y BIOFARMACEUTICA.|