Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg
2 other identifiers
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJune 6, 2011
May 1, 2011
3.1 years
April 27, 2011
June 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
Metformin
EXPERIMENTAL500 mg
Interventions
Eligibility Criteria
You may qualify if:
- Within 10% of their ideal body weight
- Age between 18 and 50 years
- Healthy conditions
- Ability to understand the written informed consent
You may not qualify if:
- Pregnancy
- Smokers
- Alcohol and drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biocineselead
Study Sites (1)
Biocinese
Toledo, Paraná, 85903-590, Brazil
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josélia Manfio, Dr
Biocinese
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 27, 2011
First Posted
June 6, 2011
Study Start
June 1, 2008
Primary Completion
July 1, 2011
Study Completion
December 1, 2011
Last Updated
June 6, 2011
Record last verified: 2011-05