BIOAVAILABILITY OF GLI/METXR (4/850 mg)

NCT01437800 | Completed Phase 1 DMC

• 1 other identifier: GLMT12-SIL
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The purpose of this study is to evaluate the oral bioavailability of the combination Glimepiride/ extended release Metformin (GLI/METXR) (4/850mg) in healthy Mexican volunteers in fasting conditions. Methods: A prospective, longitudinal, open label, non randomized study, was performed, 24 volunteers were administrated with a single oral dose of GLI/METXR (4/850 mg).

Conditions

Healthy

Keywords

DM2; glimepiride; metformin 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)

Glimepiride / Extended release Metformin

EXPERIMENTAL

Pharmaceutical Form: Tablets Dosage: (4/850 mg). Administration way: Oral On fasting conditions

Drug: Glimepiride / Extended release Metformin (4/850 mg).

Interventions

Glimepiride / Extended release Metformin (4/850 mg). DRUG

One tablet of Glimepiride/metformin extended release (4/850 mg) was administered as a single oral dose, to all patient in fasting.

Also known as: GLIMETXR

Glimepiride / Extended release Metformin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (1)

Investigacion Farmacologica Y Biofarmaceutica, S.A. de C.V.

México, 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: 1490793 RESULT

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

  PMID: 8569826 RESULT

• 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: 9793597 RESULT

• 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: 9209206 RESULT

• 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: 10454950 RESULT

MeSH Terms

Interventions

glimepiride

Study Officials

• Yamanqui Ibañez, M.D

  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)