Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: metformin ER; Drug: metformin

• Registration Number: NCT00941239
• Lead Sponsor: Laboratorios Silanes S.A. de C.V.

Brief Summary

The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of an extended release metformin compared with an immediate release metformin in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Study First Submitted: 2009-07-15
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-26
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Mexican healthy subjects with normal clinical laboratory test results and imaging (hematology, blood chemistry, urine test, VDRL, Hepatitis B, HIV, chest radiography and electrocardiogram)

Exclusion Criteria

• Familiar or personal history of diabetes
• History of drug or alcohol abuse within the 2 years prior to the study
• A smoking habit greater than 10 cigarettes per day
• History of allergy to the study drugs
• Intercurrent disease
• Intercurrent treatment with any drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin ER	metformin ER	Extended Release Metformin
metformin	metformin	Immediate release metformin

Primary Outcome Measures

Name	Time	Method
Plasmatic drug concentration	48 hours (7.5, 15,30,45,60,75,90,120,150,180,205,240,360,480,600,720,1440,2880 min and days : 3,5,7,14,21,28,30,35)

Secondary Outcome Measures

Name	Time	Method
Lanza score	30 days (0 and 30)
plasmatic glucose	30 days (0, 6, 12 and 18 hours and days: 2,5,7,14,21,28,30 and 35)
Glycated hemoglobin	30 days (days: 0, 14 and 30)

Trial Locations

Locations (1)

Pharmacology and toxicology department, UANL; 🇲🇽 Monterrey, Nuevo León, Mexico