Nutritional and Metabolic Diseases
Conditions
Keywords
Metformine, adverse events, bioequivalence
Brief summary
The objective is evaluate, in healthy volunteers, the bioavailability of two products containing metformine 500 mg to determine if they are bioequivalent and identify the occurrence of adverse events.
Detailed description
OBJECTIVE: To evaluate, in healthy volunteers, the bioavailability of two products containing metformine 500 mg to determine if they are bioequivalent and identify the occurrence of adverse events. MATERIAL AND METHODS: The study was approved by research Ethics Committee and all twenty-eight volunteers signed the selected IC. An open, randomized, crossover study with two periods of confinement and an interval of seven days between them was performed. Twenty (20) blood collections were performed between 30 minutes and 36 hours after drug administration. Plasma samples were analyzed by liquid chromatography mass spectrometry (LC-MS/MS). Statistical analysis was conducted based on pharmacokinetic parameters: maximum concentration (Cmax) and area under the curve (AUC 0-te AUC 0-inf). Analysis of variance (ANOVA) model appropriate was employed for the two periods cross under the logarithmically transformed data.
Interventions
DRUGMetformin
500 mg tablet
DRUGGlifage
500 mg tablet
Sponsors
Biocinese
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Within 10% of their ideal body weight * Age between 18 and 50 years * Healthy conditions * Ability to understand the written informed consent
Exclusion criteria
* Pregnancy * Smokers * Alcohol and drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events | Participants will be followed for the duration of hospital stay, an expected average of 24 hours. All adverse events observed are analyzed. | Observation of adverse events after a single dose. After administration, the volunteers need to answer the question: how are you? All complains are registered. The adverse events are going to be classified as linked ou not with the drug. The expected result is x volunteers presented adverse events, the most frequent was y event, and so one. |
Countries
Brazil
Outcome results
None listed