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NCT00960882 Clinical Trial

Gastric Tolerability and Pharmacokinetics of DMMET-01

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00960882
Other study ID # DMMET 1011/07
Secondary ID
Status Completed
Phase Phase 1
First received August 14, 2009
Last updated January 26, 2018
Start date June 2007
Est. completion date April 2008

Study information
Verified date January 2018
Source Laboratorios Silanes S.A. de C.V.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date April 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• DMMET-01
1050.6 mg daily for 30 days

Locations
Country Name City State
Mexico Pharmacology and toxicology department, UANL Monterrey Nuevo León

Sponsors (1)
Lead Sponsor Collaborator
Laboratorios Silanes S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Lanza score 30 days (0 and 30)
Secondary plasmatic glucose 24 hours (6,12,18 and 24)
Secondary glycated hemoglobin 24 hours (0 and 24)
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