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

August 14, 2009
August 14, 2009
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) ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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
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
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00960882
DMMET 1011/07
Yes
Dr. Jorge González Canudas, 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.
August 2009

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