Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER)
January 26, 2018 updated by: Laboratorios Silanes S.A. de C.V.
Gastric Tolerability and Pharmacokinetics of an Extended Release Metformin and an Immediate Release Metformin
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 Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nuevo León
-
Monterrey, Nuevo León, Mexico, 64460
- Pharmacology and toxicology department, UANL
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: metformin ER
Extended Release Metformin
|
850mg daily for 30 days
Other Names:
|
|
Active Comparator: metformin
Immediate release metformin
|
850 mg daily for 30 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
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 Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Lanza score
Time Frame: 30 days (0 and 30)
|
30 days (0 and 30)
|
|
plasmatic glucose
Time Frame: 30 days (0, 6, 12 and 18 hours and days: 2,5,7,14,21,28,30 and 35)
|
30 days (0, 6, 12 and 18 hours and days: 2,5,7,14,21,28,30 and 35)
|
|
Glycated hemoglobin
Time Frame: 30 days (days: 0, 14 and 30)
|
30 days (days: 0, 14 and 30)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Oscar Torres, Ph D, UANL, Pharmacology and toxicology department
- Study Director: Jorge A Gonzalez, Laboratorios Silanes S.A. de C.V.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
February 1, 2007
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
July 15, 2009
First Submitted That Met QC Criteria
July 16, 2009
First Posted (Estimate)
July 17, 2009
Study Record Updates
Last Update Posted (Actual)
January 30, 2018
Last Update Submitted That Met QC Criteria
January 26, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Met-LP 1007/06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.