Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER) - Full Text View

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:

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

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

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:

Blonde L, Dailey GE, Jabbour SA, Reasner CA, Mills DJ. Gastrointestinal tolerability of extended-release metformin tablets compared to immediate-release metformin tablets: results of a retrospective cohort study. Curr Med Res Opin. 2004 Apr;20(4):565-72.

Hale TW, Kristensen JH, Hackett LP, Kohan R, Ilett KF. Transfer of metformin into human milk. Diabetologia. 2002 Nov;45(11):1509-14. Epub 2002 Sep 25.

Stumvoll M, Nurjhan N, Perriello G, Dailey G, Gerich JE. Metabolic effects of metformin in non-insulin-dependent diabetes mellitus. N Engl J Med. 1995 Aug 31;333(9):550-4.

Brown BW Jr. The crossover experiment for clinical trials. Biometrics. 1980 Mar;36(1):69-79.

Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80.

Westlake WJ. Symmetrical confidence intervals for bioequivalence trials. Biometrics. 1976 Dec;32(4):741-4.

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 May 16, 2013