|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT00960882 |
|
Date of registration:
|
14/08/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Gastric Tolerability and Pharmacokinetics of DMMET-01
|
|
Scientific title:
|
Gastric Tolerability and Pharmacokinetics of DMMET-01. Daily Intake for 30 Days, in Normal Alimentation Conditions, in Healthy Volunteers. |
|
Date of first enrolment:
|
June 2007 |
|
Target sample size:
|
12 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00960882 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
Mexico
| | | | | | | |
|
Contacts
|
|
Name:
|
Oscar Torres, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
UANL, Pharmacology and toxicology department |
|
|
Name:
|
Jorge A Gonzalez, Master |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Laboratorios Silanes S.A. de C.V. |
| |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Healthy
|
|
Intervention(s)
|
|
Drug: DMMET-01
|
|
Primary Outcome(s)
|
|
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 Outcome(s)
|
|
glycated hemoglobin
[Time Frame: 24 hours (0 and 24)]
|
|
Lanza score
[Time Frame: 30 days (0 and 30)]
|
|
plasmatic glucose
[Time Frame: 24 hours (6,12,18 and 24)]
|
|
Secondary ID(s)
|
|
DMMET 1011/07
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|