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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 : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Laboratorios Silanes S.A. de C.V.

August 14, 2009
August 18, 2009
January 30, 2018
June 2007
March 2008   (Final data collection date for primary outcome measure)
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) ]
Same as current
Complete list of historical versions of study NCT00960882 on ClinicalTrials.gov Archive Site
  • 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) ]
Same as current
Not Provided
Not Provided
 
Gastric Tolerability and Pharmacokinetics of DMMET-01
Gastric Tolerability and Pharmacokinetics of DMMET-01. Daily Intake for 30 Days, in Normal Alimentation Conditions, in Healthy Volunteers.
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
Drug: DMMET-01
1050.6 mg daily for 30 days
Experimental: DMMET-01
Intervention: Drug: DMMET-01
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Same as current
April 2008
March 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT00960882
DMMET 1011/07
Yes
Not Provided
Plan to Share IPD: Undecided
Laboratorios Silanes S.A. de C.V.
Laboratorios Silanes S.A. de C.V.
Not Provided
Principal Investigator: Oscar Torres, PhD UANL, Pharmacology and toxicology department
Study Director: Jorge A Gonzalez, Master Laboratorios Silanes S.A. de C.V.
Laboratorios Silanes S.A. de C.V.
January 2018

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