Trial | NCT01367054  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    sitagliptin ...

  • Study Participants

    26
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.
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 Started
Jun 30
2008
Primary Completion
Jul 31
2011
Anticipated
Study Completion
Dec 31
2011
Anticipated
Last Update
Jun 06
2011
Estimate

Drug Metformin

500 mg tablet

  • Other names: Test

Drug Glifage

500 mg tablet

  • Other names: Reference

Metformin Experimental

500 mg

Criteria 

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
No Results Posted