Open-label Crossover Metformin Gum Versus Tablet in Healt... | NCT00648869

Studies
Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers

NCT00648869

Sponsor

Hadassah Medical Organization

Status

Withdrawn

Last Update Posted

Oct 27, 2009Estimated

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

metformin tablet, metformin gum

Countries

Israel

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

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Drug was not sent

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Oct 2008Estimated

Completion Date

Nov 2008Estimated

First Submitted Date

Mar 27, 2008

First Submission Date that Met QC Criteria

Mar 31, 2008

First Posted Date

Apr 1, 2008Estimated

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

Oct 25, 2009

Last Update Posted Date

Oct 27, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Single-dose, randomized, open-label, cross over study. The study will have an open-label, 3 period, 3 treatments, and randomized design.

Each volunteer will receive a Metformin gum 2x250mg, Metformin gum 1x250mg & Metformin tablet 500mg

Detailed Description

Not provided

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

12Estimated

Name	Type	Description	Arm Group Labels	Other Names
metformin tablet, metformin gum	Drug	500 mg, 250 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet).		45 days

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the effect on blood glucose levels as well as safety and tolerability of one time administration of the Metformin Gum and Metformin tablet.		45 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men ranging in age from 18-40
Good general health as determined by medical history, physical examination, ECG, Blood pressure, and clinical laboratory tests (hematology & clinical chemistry) obtained within 14 days prior to the start of the study.
BMI >18&<30.
Willing and able to abide by the dietary requirements of the study.
Willing and able to give written informed consent in a manner approved by the Ethics Committee.

Exclusion Criteria:

History of known or suspected clinically significant hypersensitivity to any drug.
Any protocol-required laboratory test abnormality that is considered clinically significant.
Mentally unstable or incompetent.
Any illness during the week before.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Itamar Raz, MD	Hadassah Hebrew University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diabetes Unit, Hadassah Hebew University Hospital		Jerusalem		91120	Israel

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