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

Not Applicable

• Conditions: Nutritional and Metabolic Diseases
• Interventions: Drug: Metformin; Drug: Glifage

• Registration Number: NCT01367054
• Lead Sponsor: Biocinese

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2011-04-27
• Status Verified: 2011-05
• Study First Submitted QC: 2011-06-03
• Last Update Submitted: 2011-06-03
• Study First Posted: 2011-06-06
• Last Update Posted: 2011-06-06
• Primary Completion: 2011-07
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Within 10% of their ideal body weight
• Age between 18 and 50 years
• Healthy conditions
• Ability to understand the written informed consent

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Exclusion Criteria

• Pregnancy
• Smokers
• Alcohol and drugs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	500 mg
Metformin	Glifage	500 mg

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	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.

Trial Locations

Locations (1)

Biocinese; 🇧🇷 Toledo, Pr, Brazil