Trial | NCT00941239  Report issue

Title

Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER)
Gastric Tolerability and Pharmacokinetics of an Extended Release Metformin and an Immediate Release Metformin

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    sitagliptin ...

  • Study Participants

    24
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.
Study Started
Jan 31
2007
Primary Completion
Feb 28
2007
Study Completion
Feb 28
2007
Last Update
Jan 30
2018

Drug metformin ER

850mg daily for 30 days

  • Other names: predial plus

Drug metformin

850 mg daily for 30 days

  • Other names: extended release predial plus

metformin ER Experimental

Extended Release Metformin

metformin Active Comparator

Immediate release metformin

Criteria 

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
No Results Posted