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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nutritional and Metabolic Diseases

Intervention / Treatment
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* Drug: Metformin
* Drug: Glifage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin<br>500 mg | Drug: Metformin<br>* 500 mg tablet<br>* Other names: Test;Drug: Glifage<br>* 500 mg tablet<br>* Other names: Reference;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | 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. | Participants will be followed for the duration of hospital stay, an expected average of 24 hours. All adverse events observed are analyzed. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metformine, adverse events, bioequivalence