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

This study has been completed.
Information provided by (Responsible Party):
Laboratorios Silanes S.A. de C.V. Identifier:
First received: July 15, 2009
Last updated: October 22, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Healthy Drug: metformin ER Drug: metformin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Gastric Tolerability and Pharmacokinetics of an Extended Release Metformin and an Immediate Release Metformin

Resource links provided by NLM:

Further study details as provided by Laboratorios Silanes S.A. de C.V.:

Primary Outcome Measures:
  • Plasmatic drug concentration [ Time Frame: 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:
  • Lanza score [ Time Frame: 30 days (0 and 30) ]
  • plasmatic glucose [ Time Frame: 30 days (0, 6, 12 and 18 hours and days: 2,5,7,14,21,28,30 and 35) ]
  • Glycated hemoglobin [ Time Frame: 30 days (days: 0, 14 and 30) ]

Enrollment: 24
Study Start Date: January 2007
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: metformin ER
Extended Release Metformin
Drug: metformin ER
850mg daily for 30 days
Other Name: predial plus
Active Comparator: metformin
Immediate release metformin
Drug: metformin
850 mg daily for 30 days


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00941239

Pharmacology and toxicology department, UANL
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Principal Investigator: Oscar Torres, Ph D UANL, Pharmacology and toxicology department
Study Director: Jorge A Gonzalez Laboratorios Silanes S.A. de C.V.
  More Information

Responsible Party: Laboratorios Silanes S.A. de C.V. Identifier: NCT00941239     History of Changes
Other Study ID Numbers: Met-LP 1007/06
Study First Received: July 15, 2009
Last Updated: October 22, 2015

Keywords provided by Laboratorios Silanes S.A. de C.V.:
Metformin ER
Healthy volunteers

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on August 22, 2017