BIOAVAILABILITY OF Glimepiride/Extended Release Metformin (GLI/METXR): High Fat Diet Study

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Silanes S.A. de C.V.
• Collaborator: Instituto Mexicano del Seguro Social
• Treatments: Glimepiride; Metformin

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