Gastric Tolerability and Pharmacokinetics of DMMET-01

This study has been completed.

Sponsor:

Information provided by:

Laboratorios Silanes S.A. de C.V.

ClinicalTrials.gov Identifier:

NCT00960882

First received: August 14, 2009

Last updated: NA

Last verified: August 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

August 14, 2009

Last Updated Date

August 14, 2009

Start Date ^ICMJE

June 2007

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

DMMET-01 Plasmatic concentration [ Time Frame: 48 hrs (7.5; 15; 30; 45; 60; 75; 90; 120; 150; 180; 205; 240; 360; 480; 600; 720; 1440 and 2880 min) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Lanza score [ Time Frame: 30 days (0 and 30) ] [ Designated as safety issue: Yes ]
plasmatic glucose [ Time Frame: 24 hours (6,12,18 and 24) ] [ Designated as safety issue: Yes ]
glycated hemoglobin [ Time Frame: 24 hours (0 and 24) ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Gastric Tolerability and Pharmacokinetics of DMMET-01

Official Title ^ICMJE

Gastric Tolerability and Pharmacokinetics of DMMET-01. Daily Intake for 30 Days, in Normal Alimentation Conditions, in Healthy Volunteers.

Brief Summary

The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of a new drug for the treatment of type 2 diabetes, DMMET-01, in healthy volunteers.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: DMMET-01

1050.6 mg daily for 30 days

Study Arm (s)

Experimental: DMMET-01

Intervention: Drug: DMMET-01

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 tha 10 cigarettes per day
Intercurrent disease
Intercurrent treatment with any drug

Gender

Both

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Mexico

Administrative Information

NCT Number ^ICMJE

NCT00960882

Other Study ID Numbers ^ICMJE

DMMET 1011/07

Has Data Monitoring Committee

Yes

Responsible Party

Dr. Jorge González Canudas, Laboratorios Silanes S.A. de C.V.

Study Sponsor ^ICMJE

Laboratorios Silanes S.A. de C.V.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Oscar Torres, PhD	UANL, Pharmacology and toxicology department
Study Director:	Jorge A Gonzalez, Master	Laboratorios Silanes S.A. de C.V.

Information Provided By

Laboratorios Silanes S.A. de C.V.

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top