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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00941239
Recruitment Status : Completed
First Posted : July 17, 2009
Last Update Posted : January 30, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: metformin ER Drug: metformin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Study Start Date : January 2007
Primary Completion Date : February 2007
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
Other Name: extended release predial plus

Primary Outcome Measures :
  1. 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 :
  1. Lanza score [ Time Frame: 30 days (0 and 30) ]
  2. plasmatic glucose [ Time Frame: 30 days (0, 6, 12 and 18 hours and days: 2,5,7,14,21,28,30 and 35) ]
  3. Glycated hemoglobin [ Time Frame: 30 days (days: 0, 14 and 30) ]

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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.

Responsible Party: Laboratorios Silanes S.A. de C.V. Identifier: NCT00941239     History of Changes
Other Study ID Numbers: Met-LP 1007/06
First Posted: July 17, 2009    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs