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
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 14, 2009
Last Updated: August 14, 2009
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

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

ClinicalTrials.gov processed this record on July 23, 2014