Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg

Nutritional and Metabolic Diseases Clinical Trial

Official title: Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Diseases

• NCT number: NCT01367054
• Study type: Interventional
• Source: Biocinese
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2008
• Completion date: December 2011