Gastric Tolerability and Pharmacokinetics of DMMET-01

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00960882

Enrollment

Registered

2009-08-18

Start date

2007-06-30

Completion date

2008-04-30

Last updated

2018-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pharmacokinetics, Diabetes, gastric tolerability

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.

Interventions

DRUGDMMET-01

1050.6 mg daily for 30 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Lanza score	30 days (0 and 30)
plasmatic glucose	24 hours (6,12,18 and 24)
glycated hemoglobin	24 hours (0 and 24)

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026