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NCT00941239 Clinical Trial

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

Healthy Clinical Trial

Official title:
Gastric Tolerability and Pharmacokinetics of an Extended Release Metformin and an Immediate Release Metformin

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00941239
Other study ID # Met-LP 1007/06
Secondary ID
Status Completed
Phase Phase 1
First received July 15, 2009
Last updated January 26, 2018
Start date January 2007
Est. completion date February 2007

Study information
Verified date January 2018
Source Laboratorios Silanes S.A. de C.V.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• metformin ER
850mg daily for 30 days
• metformin
850 mg daily for 30 days

Locations
Country Name City State
Mexico Pharmacology and toxicology department, UANL Monterrey Nuevo León

Sponsors (1)
Lead Sponsor Collaborator
Laboratorios Silanes S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

References & Publications (7)

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. — View Citation

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

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. — View 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. — View 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. — View Citation

The United States Pharmacopeia USP26. Pags 525-526. 2003. Rockville. MD.

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

Outcome
Type Measure Description Time frame Safety issue
Primary Plasmatic drug concentration 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 Lanza score 30 days (0 and 30)
Secondary plasmatic glucose 30 days (0, 6, 12 and 18 hours and days: 2,5,7,14,21,28,30 and 35)
Secondary Glycated hemoglobin 30 days (days: 0, 14 and 30)
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