Gastric Tolerability and Pharmacokinetics of DMMET-01

Laboratorios Silanes S.A. de C.V.12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

DMMET-01DRUG

1050.6 mg daily for 30 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pharmacology and toxicology department, UANL

Monterrey, Nuevo León, Mexico

Outcomes

Primary Outcomes

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

Lanza score

Time frame: 30 days (0 and 30)

plasmatic glucose

Time frame: 24 hours (6,12,18 and 24)

glycated hemoglobin

Time frame: 24 hours (0 and 24)

Data from ClinicalTrials.gov

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