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

Laboratorios Silanes

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: metformin ER; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00941239

Met-LP 1007/06

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

metformin ER

Experimental group

Description:

Extended Release Metformin

Treatment:

Drug: metformin ER

metformin

Active Comparator group

Description:

Immediate release metformin

Treatment:

Drug: metformin