Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg
This trial is active, not recruiting.
|Condition||nutritional and metabolic diseases|
|Start date||June 2008|
|End date||July 2011|
|Trial size||26 participants|
|Trial identifier||NCT01367054, 06/2008, Met 2005|
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.
|Endpoint classification||bio-equivalence study|
|Intervention model||crossover assignment|
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.
Male or female participants from 18 years up to 50 years old.
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
|Official title||Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg|
|Principal investigator||Josélia Manfio, Dr|
|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.|
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