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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Biocinese.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Biocinese
ClinicalTrials.gov Identifier:
NCT01367054
First received: April 27, 2011
Last updated: June 3, 2011
Last verified: May 2011
  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 Intervention
Nutritional and Metabolic Diseases
Drug: Metformin
Drug: Glifage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg

Resource links provided by NLM:


Further study details as provided by Biocinese:

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.


Estimated Enrollment: 26
Study Start Date: June 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin
500 mg
Drug: Metformin
500 mg tablet
Other Name: Test
Drug: Glifage
500 mg tablet
Other Name: Reference

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367054

Locations
Brazil
Biocinese
Toledo, Pr, Brazil, 85903-590
Sponsors and Collaborators
Biocinese
Investigators
Principal Investigator: Josélia Manfio, Dr Biocinese
  More Information

Additional Information:
No publications provided

Responsible Party: Josélia Larger Manfio, Biocinese
ClinicalTrials.gov Identifier: NCT01367054     History of Changes
Other Study ID Numbers: 06/2008, Met 2005
Study First Received: April 27, 2011
Last Updated: June 3, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Biocinese:
Metformine
adverse events
bioequivalence

Additional relevant MeSH terms:
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014