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Gastric Tolerability and Pharmacokinetics of DMMET-01

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ClinicalTrials.gov Identifier: NCT00960882
Recruitment Status : Completed
First Posted : August 18, 2009
Last Update Posted : August 18, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: DMMET-01 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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.
Study Start Date : June 2007
Primary Completion Date : March 2008
Study Completion Date : April 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: DMMET-01 Drug: DMMET-01
1050.6 mg daily for 30 days


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Lanza score [ Time Frame: 30 days (0 and 30) ]
  2. plasmatic glucose [ Time Frame: 24 hours (6,12,18 and 24) ]
  3. glycated hemoglobin [ Time Frame: 24 hours (0 and 24) ]

Eligibility Criteria

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 Posted: August 18, 2009    Key Record Dates
Last Update Posted: August 18, 2009
Last Verified: August 2009

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