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Gastric Tolerability and Pharmacokinetics of DMMET-01

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00960882
First Posted: August 18, 2009
Last Update Posted: August 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Laboratorios Silanes S.A. de C.V.
  Purpose
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.

Condition Intervention Phase
Healthy Drug: DMMET-01 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gastric Tolerability and Pharmacokinetics of DMMET-01. Daily Intake for 30 Days, in Normal Alimentation Conditions, in Healthy Volunteers.

Further study details as provided by Laboratorios Silanes S.A. de C.V.:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • Lanza score [ Time Frame: 30 days (0 and 30) ]
  • plasmatic glucose [ Time Frame: 24 hours (6,12,18 and 24) ]
  • glycated hemoglobin [ Time Frame: 24 hours (0 and 24) ]

Enrollment: 12
Study Start Date: June 2007
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DMMET-01 Drug: DMMET-01
1050.6 mg daily for 30 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 tha 10 cigarettes per day
  • Intercurrent disease
  • Intercurrent treatment with any drug
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960882


Locations
Mexico
Pharmacology and toxicology department, UANL
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Investigators
Principal Investigator: Oscar Torres, PhD UANL, Pharmacology and toxicology department
Study Director: Jorge A Gonzalez, Master Laboratorios Silanes S.A. de C.V.
  More Information

Responsible Party: Dr. Jorge González Canudas, Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier: NCT00960882     History of Changes
Other Study ID Numbers: DMMET 1011/07
First Submitted: August 14, 2009
First Posted: August 18, 2009
Last Update Posted: August 18, 2009
Last Verified: August 2009

Keywords provided by Laboratorios Silanes S.A. de C.V.:
Pharmacokinetics
Diabetes
gastric tolerability