BIOAVAILABILITY OF Glimepiride/Extended Release Metformin (GLI/METXR): High Fat Diet Study (GLMT13)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Bioavailability of Glimepiride/Extended Release Metformin (4/850 mg) After a High Fat Diet, in Healthy Mexican Volunteers|
- 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
- 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.
|Study Start Date:||January 2011|
|Study Completion Date:||March 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Drug: Glimepiride/extended release Metformin
|Investigación Farmacológica Y Biofarmaceutica, S.A. de C.V.|
|México, Mexico, 14610|
|Principal Investigator:||Yamanqui Ibañez, Dr.||INVESTIGACIÓN FARMACOLÓGICA Y BIOFARMACEUTICA.|