Clinical trial NCT00941239: Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER)
Official title: Gastric Tolerability and Pharmacokinetics of an Extended Release Metformin and an Immediate Release Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Metformin ER
Pharmacokinetics
Tolerability
Healthy volunteers
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2009-07-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Plasmatic drug concentration
timeFrame: 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:
measure: Lanza score
timeFrame: 30 days (0 and 30)
measure: plasmatic glucose
timeFrame: 30 days (0, 6, 12 and 18 hours and days: 2,5,7,14,21,28,30 and 35)
measure: Glycated hemoglobin
timeFrame: 30 days (days: 0, 14 and 30)
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Pharmacology and toxicology department, UANL
state: Nuevo León
Study officials:
affiliation: UANL, Pharmacology and toxicology department
name: Oscar Torres, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratorios Silanes S.A. de C.V.
name: Jorge A Gonzalez
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1185/030079904125003278.
citation: Hale TW, Kristensen JH, Hackett LP, Kohan R, Ilett KF. Transfer of metformin into human milk. Diabetologia. 2002 Nov;45(11):1509-14. doi: 10.1007/s00125-002-0939-x. Epub 2002 Sep 25.
citation: 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. doi: 10.1056/NEJM199508313330903.
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citation: 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. doi: 10.1007/BF01068419.
citation: Westlake WJ. Symmetrical confidence intervals for bioequivalence trials. Biometrics. 1976 Dec;32(4):741-4.
citation: The United States Pharmacopeia USP26. Pags 525-526. 2003. Rockville. MD.