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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Nutritional and Metabolic Diseases
Intervention	Drug: Metformin Drug: Glifage
Phase	N/A
Sponsor	Biocinese
Responsible Party	Biocinese
ClinicalTrials.gov Identifier	NCT01367054
First Received	April 27, 2011
Last Updated	June 3, 2011
Last verified	May 2011

Tracking Information[ + expand ][ + ]

First Received Date	April 27, 2011
Last Updated Date	June 3, 2011
Start Date	June 2008
Estimated Primary Completion Date	December 2011
Current Primary Outcome Measures	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.] [Designated as safety issue: No]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.
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg
Official Title	Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg
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.
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Condition	Nutritional and Metabolic Diseases
Intervention	Drug: Metformin 500 mg tablet Other Names: TestDrug: Glifage 500 mg tablet Other Names: Reference
Study Arm (s)	Experimental: Metformin 500 mg

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	26
Estimated Completion Date	December 2011
Estimated Primary Completion Date	July 2011
Eligibility 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Brazil

Administrative Information[ + expand ][ + ]

NCT Number	NCT01367054
Other Study ID Numbers	06/2008
Has Data Monitoring Committee	No
Information Provided By	Biocinese
Study Sponsor	Biocinese
Collaborators	Not Provided
Investigators	Principal Investigator: Josélia Manfio, Dr Biocinese
Verification Date	May 2011

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