BIOAVAILABILITY OF GLI/METXR (4/850 mg) (GLMT12-SIL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01437800|
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : September 21, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Glimepiride/extended release Metformin (4/850 mg).||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) 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 (4/850 mg).
One tablet of Glimepiride/metformin extended release (4/850 mg) was administered as a single oral dose, to all patient in fasting.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): NCT01437800
|Investigacion Farmacologica Y Biofarmaceutica, S.A. de C.V.|
|Principal Investigator:||Yamanqui Ibañez, Dr.||INVESTIGACIÓN FARMACOLÓGICA Y BIOFARMACEUTICA.|