Adverse Events in Pharmaceutical Bioequivalence Study of... | NCT01367054

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

NCT01367054

Sponsor

Biocinese

Status

Unknown status

Last Update Posted

Jun 6, 2011Estimated

Enrollment

26Estimated

Phase

Not Applicable

Conditions

Nutritional and Metabolic Diseases

Interventions

Metformin
Glifage

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Met 2005	Other Identifier	Biocinese

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jul 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Apr 27, 2011

First Submission Date that Met QC Criteria

Jun 3, 2011

First Posted Date

Jun 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2011

Last Update Posted Date

Jun 6, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metformin	Experimental	500 mg	Drug: Metformin Drug: Glifage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug	500 mg tablet	Metformin	Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Josélia Manfio, Dr	Biocinese	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Biocinese		Toledo	Paraná	85903-590	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D009750	Nutritional and Metabolic Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided