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

This study has been completed.
Sponsor:
Information provided by:
Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT00941239
First received: July 15, 2009
Last updated: July 16, 2009
Last verified: July 2009
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lanza score [ Time Frame: 30 days (0 and 30) ] [ Designated as safety issue: Yes ]
  • plasmatic glucose [ Time Frame: 30 days (0, 6, 12 and 18 hours and days: 2,5,7,14,21,28,30 and 35) ] [ Designated as safety issue: Yes ]
  • Glycated hemoglobin [ Time Frame: 30 days (days: 0, 14 and 30) ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mexican healthy subjects with normal clinical laboratory test results and imaging (hematology, blood chemistry, urine test, VDRL, Hepatitis B, VIH, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941239

Locations
Mexico
Pharmacology and toxicology department, UANL
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Investigators
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

Publications:
Responsible Party: Jorge González Canudas, Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier: NCT00941239     History of Changes
Other Study ID Numbers: Met-LP 1007/06
Study First Received: July 15, 2009
Last Updated: July 16, 2009
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

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

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014