NCT01437813

Brief Summary

Objective: The purpose of this study is to evaluate the effect of food intake in bioavailability (BA) of the combination Glimepiride/ extended release Metformin GLI/METXR (4/850mg) in healthy Mexican volunteers. Methods: A prospective, longitudinal, open label, non randomized study, was performed. A single oral dose of GLI/METXR (4/850 mg) was administered to 24 health Mexican volunteers 30 min after a high fat meal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

Same day

First QC Date

September 19, 2011

Last Update Submit

May 3, 2021

Conditions

Healthy

Keywords

DM2glimepiridemetformin extended release

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic Profile

    Cmax, Area Under Curve, Tmax

    Predose,0.25, 0.5, 0.75, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16,20, 24 y 30 hours post-dose

Secondary Outcomes (1)

  • Adverse Events

    0.25, 0.5, 0.75, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16,20, 24 y 30 hours post-dose

Study Arms (1)

Group A: Glimepiride / Extended Release Metformin

EXPERIMENTAL

Pharmaceutical Form: Tablets Dosage: 4 mg / 850 mg Administration way: Oral

Drug: Glimepiride/ Extended release Metformin

Interventions

Glimepiride/ Extended release MetforminDRUG

One tablet of Glimepiride/metformin extended release (4/850 mg) was administered as a single oral dose. Patients received a high fat diet 30 min before administration.

Also known as: GLIMETXR
Group A: Glimepiride / Extended Release Metformin

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Mexican volunteers, considered healthy according to standard screening assessments
  • Aged between 18 and 50 years old
  • Body mass index (BMI) was 18 to 27.5

You may not qualify if:

  • Those with a history or evidence of cardiovascular, renal, hepatic, gastrointestinal, neurologic, muscular, metabolic, or hematologic abnormality
  • Any acute or chronic disease
  • Any drug allergy and female volunteers positive to urinary pregnancy test or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigación Farmacológica Y Biofarmaceutica, S.A. de C.V.

México, 14610, Mexico

Location

Related Publications (5)

  • Badian M, Korn A, Lehr KH, Malerczyk V, Waldhausl W. Determination of the absolute bioavailability of glimepiride (HOE 490), a new sulphonylurea. Int J Clin Pharmacol Ther Toxicol. 1992 Nov;30(11):481-2. No abstract available.

    PMID: 1490793RESULT

  • Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996 Feb 29;334(9):574-9. doi: 10.1056/NEJM199602293340906. No abstract available.

    PMID: 8569826RESULT

  • Campbell RK. Glimepiride: role of a new sulfonylurea in the treatment of type 2 diabetes mellitus. Ann Pharmacother. 1998 Oct;32(10):1044-52. doi: 10.1345/aph.17360.

    PMID: 9793597RESULT

  • Davidson MB, Peters AL. An overview of metformin in the treatment of type 2 diabetes mellitus. Am J Med. 1997 Jan;102(1):99-110. doi: 10.1016/s0002-9343(96)00353-1.

    PMID: 9209206RESULT

  • DeFronzo RA. Pharmacologic therapy for type 2 diabetes mellitus. Ann Intern Med. 1999 Aug 17;131(4):281-303. doi: 10.7326/0003-4819-131-4-199908170-00008.

    PMID: 10454950RESULT

MeSH Terms

Interventions

glimepiride

Study Officials

  • Yamanqui Ibañez, Dr.

    INVESTIGACIÓN FARMACOLÓGICA Y BIOFARMACEUTICA.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2011

First Posted

September 21, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2011

Study Completion

March 1, 2011

Last Updated

May 6, 2021

Record last verified: 2021-05

Locations

ME(1)