BIOAVAILABILITY OF GLI/METXR (4/850 mg) (GLMT12-SIL)
The purpose of this study is to evaluate the oral bioavailability 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, 24 volunteers were administrated with a single oral dose of GLI/METXR (4/850 mg). Blood samples were collected over 30 hours. Plasma concentration of both drugs were measured by using high-performance liquid chromatography (HPLC). Plasma concentration-time curves were plotted for each volunteer, and pharmacokinetic parameters (PK) were calculated. Adverse events were determined using clinical and laboratory test results, throughout the study.
|Healthy||Drug: Glimepiride/extended release Metformin (4/850 mg).||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Bioavailability of Glimepiride/Extended Release Metformin (4/850 mg) 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 ]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.
|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 (4/850 mg).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437800
|Investigacion Farmacologica Y Biofarmaceutica, S.A. de C.V.|
|Principal Investigator:||Yamanqui Ibañez, Dr.||INVESTIGACIÓN FARMACOLÓGICA Y BIOFARMACEUTICA.|