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

Nutritional and Metabolic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01367054
• Other study ID #: 06/2008
• Secondary ID: Met 2005
• Status: Active, not recruiting
• Phase: N/A
• First received: April 27, 2011
• Last updated: June 3, 2011
• Start date: June 2008
• Est. completion date: December 2011

Study information

• Verified date: May 2011
• Source: Biocinese
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Diseases

Intervention

Drug:
• Metformin
500 mg tablet
• Glifage
500 mg tablet

Locations

Country	Name	City	State
Brazil	Biocinese	Toledo	Pr

Sponsors (1)

Lead Sponsor	Collaborator
Biocinese

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No

External Links

•   Information about Biocinese