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Completed

NCT Number: NCT00941239

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

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.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmacology and toxicology department, UANL

Monterrey, Nuevo León, 64460, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin ER

Drug

850mg daily for 30 days

Other names: predial plus

metformin

Drug

850 mg daily for 30 days

Other names: extended release predial plus

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Laboratorios Silanes S.A. de C.V.

Industry

Registry information

Official study title

Gastric Tolerability and Pharmacokinetics of an Extended Release Metformin and an Immediate Release Metformin

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 17, 2009
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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