Gastric Tolerability and Pharmacokinetics of DMMET-01

Laboratorios Silanes

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: DMMET-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960882

DMMET 1011/07

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

DMMET-01

Experimental group

Treatment:

Drug: DMMET-01