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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Laboratorios Silanes S.A. de C.V.
• Treatments: Metformin

Criteria

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