Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER)
NCT ID: NCT00941239
Last Updated: 2018-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2007-01-31
2007-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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metformin ER
Extended Release Metformin
metformin ER
850mg daily for 30 days
metformin
Immediate release metformin
metformin
850 mg daily for 30 days
Interventions
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metformin ER
850mg daily for 30 days
metformin
850 mg daily for 30 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
35 Years
ALL
Yes
Sponsors
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Laboratorios Silanes S.A. de C.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Oscar Torres, Ph D
Role: PRINCIPAL_INVESTIGATOR
UANL, Pharmacology and toxicology department
Jorge A Gonzalez
Role: STUDY_DIRECTOR
Laboratorios Silanes S.A. de C.V.
Locations
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Pharmacology and toxicology department, UANL
Monterrey, Nuevo León, Mexico
Countries
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References
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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.
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.
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.
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. doi: 10.1007/BF01068419.
Westlake WJ. Symmetrical confidence intervals for bioequivalence trials. Biometrics. 1976 Dec;32(4):741-4.
The United States Pharmacopeia USP26. Pags 525-526. 2003. Rockville. MD.
Other Identifiers
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Met-LP 1007/06
Identifier Type: -
Identifier Source: org_study_id
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