BIOAVAILABILITY OF GLI/METXR (4/850 mg)

• 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 oral bioavailability of the combination Glimepiride/ extended release Metformin (GLI/METXR) (4/850mg) in healthy Mexican volunteers in fasting conditions.

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).

• 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