Tolerability and Pharmacokinetics of Metformin and Metfor... | NCT00941239

Studies
Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER)

NCT00941239

Sponsor

Laboratorios Silanes S.A. de C.V.

Status

Completed

Last Update Posted

Jan 30, 2018Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy

Interventions

metformin ER
metformin

Countries

Mexico

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

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Feb 2007Actual

Completion Date

Feb 2007Actual

First Submitted Date

Jul 15, 2009

First Submission Date that Met QC Criteria

Jul 16, 2009

First Posted Date

Jul 17, 2009Estimated

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

Jan 26, 2018

Last Update Posted Date

Jan 30, 2018Actual

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

The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of an extended release metformin compared with an immediate release metformin in healthy subjects.

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
metformin ER	Experimental	Extended Release Metformin	Drug: metformin ER
metformin	Active Comparator	Immediate release metformin	Drug: metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
metformin ER	Drug	850mg daily for 30 days	metformin ER	predial plus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasmatic drug concentration		48 hours (7.5, 15,30,45,60,75,90,120,150,180,205,240,360,480,600,720,1440,2880 min and days : 3,5,7,14,21,28,30,35)

Secondary Outcomes

Measure	Description	Time Frame
Lanza score		30 days (0 and 30)
plasmatic glucose		30 days (0, 6, 12 and 18 hours and days: 2,5,7,14,21,28,30 and 35)
Glycated hemoglobin

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mexican healthy subjects with normal clinical laboratory test results and imaging (hematology, blood chemistry, urine test, VDRL, Hepatitis B, HIV, chest radiography and electrocardiogram)

Exclusion Criteria:

Familiar or personal history of diabetes
History of drug or alcohol abuse within the 2 years prior to the study
A smoking habit greater than 10 cigarettes per day
History of allergy to the study drugs
Intercurrent disease
Intercurrent treatment with any drug

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oscar Torres, Ph D	UANL, Pharmacology and toxicology department	Principal Investigator
Jorge A Gonzalez	Laboratorios Silanes S.A. de C.V.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pharmacology and toxicology department, UANL		Monterrey	Nuevo León	64460	Mexico

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15119994	Background	Blonde L, Dailey GE, Jabbour SA, Reasner CA, Mills DJ. Gastrointestinal tolerability of extended-release metformin tablets compared to immediate-release metformin tablets: results of a retrospective cohort study. Curr Med Res Opin. 2004 Apr;20(4):565-72. doi: 10.1185/030079904125003278.
12436333	Background

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals