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Completed

NCT Number: NCT00960882

Gastric Tolerability and Pharmacokinetics of DMMET-01

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.

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Key information

Conditions

Healthy Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmacology and toxicology department, UANL

Monterrey, Nuevo León, 64460, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DMMET-01

Drug

1050.6 mg daily for 30 days

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Laboratorios Silanes S.A. de C.V.

Industry

Registry information

Official study title

Gastric Tolerability and Pharmacokinetics of DMMET-01. Daily Intake for 30 Days, in Normal Alimentation Conditions, in Healthy Volunteers.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 18, 2009
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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