Gastric Tolerability and Pharmacokinetics of DMMET-01
- Registration Number
- NCT00960882
- Lead Sponsor
- Laboratorios Silanes S.A. de C.V.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DMMET-01 DMMET-01 -
- Primary Outcome Measures
Name Time Method DMMET-01 Plasmatic concentration 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
Name Time Method plasmatic glucose 24 hours (6,12,18 and 24) glycated hemoglobin 24 hours (0 and 24) Lanza score 30 days (0 and 30)
Trial Locations
- Locations (1)
Pharmacology and toxicology department, UANL
🇲🇽Monterrey, Nuevo León, Mexico