Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg
|ClinicalTrials.gov Identifier: NCT01367054|
Recruitment Status : Unknown
Verified May 2011 by Biocinese.
Recruitment status was: Active, not recruiting
First Posted : June 6, 2011
Last Update Posted : June 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Nutritional and Metabolic Diseases||Drug: Metformin Drug: Glifage||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||December 2011|
500 mg tablet
Other Name: Test
500 mg tablet
Other Name: Reference
- Number of Participants with Adverse Events [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367054
|Toledo, Pr, Brazil, 85903-590|
|Principal Investigator:||Josélia Manfio, Dr||Biocinese|