Healthy
Conditions
Keywords
Metformin ER, Pharmacokinetics, Tolerability, Healthy volunteers
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.
Interventions
DRUGmetformin ER
850mg daily for 30 days
DRUGmetformin
850 mg daily for 30 days
Sponsors
Laboratorios Silanes S.A. de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Lanza score | 30 days (0 and 30) |
| plasmatic glucose | 30 days (0, 6, 12 and 18 hours and days: 2,5,7,14,21,28,30 and 35) |
| Glycated hemoglobin | 30 days (days: 0, 14 and 30) |
Countries
Mexico
Outcome results
None listed