Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg
NCT ID: NCT01367054
Last Updated: 2011-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
26 participants
INTERVENTIONAL
2008-06-30
2011-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bioequivalence Study of Two Strengths of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects
NCT02183571
Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fed, Healthy, Adult Subjects
NCT00944346
Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet Versus Glucophage XR® 500 mg Tablet in Healthy Volunteers Under Fed Conditions
NCT01089179
Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fasting Conditions.
NCT01089192
Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fed Conditions.
NCT01089205
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Metformin
500 mg
Metformin
500 mg tablet
Glifage
500 mg tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Metformin
500 mg tablet
Glifage
500 mg tablet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age between 18 and 50 years
* Healthy conditions
* Ability to understand the written informed consent
Exclusion Criteria
* Smokers
* Alcohol and drugs
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biocinese
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Biocinese
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Josélia Manfio, Dr
Role: PRINCIPAL_INVESTIGATOR
Biocinese
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Biocinese
Toledo, Paraná, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Met 2005
Identifier Type: OTHER
Identifier Source: secondary_id
06/2008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.