Overview

This trial is active, not recruiting.

Condition nutritional and metabolic diseases
Treatments metformin, glifage
Sponsor Biocinese
Start date June 2008
End date July 2011
Trial size 26 participants
Trial identifier NCT01367054, 06/2008, Met 2005

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model crossover assignment
Masking open label
Arm
(Experimental)
500 mg
metformin Test
500 mg tablet
glifage Reference
500 mg tablet

Primary Outcomes

Measure
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.

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Biocinese.