Clinical trial NCT01437813: BIOAVAILABILITY OF Glimepiride/Extended Release Metformin (GLI/METXR): High Fat Diet Study
Official title: Bioavailability of Glimepiride/Extended Release Metformin (4/850 mg) After a High Fat Diet, in Healthy Mexican Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: DM2
glimepiride
metformin extended release
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
Collaborators: name: Instituto Mexicano del Seguro Social
First posted: 2011-09-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Blood samples were collected before the administration and 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6.7, 8, 10, 12, 16, 20, 24 and 30 hours post-administration. Plasma concentration of the drug was measured by using HPLC. Plasma concentration of both drugs were measured using high-performance liquid chromatography (HPLC). Plasma concentration time curves were plotted for each volunteers, and pharmacokinetic parameters (PK) were calculated. The pharmacokinetic parameters to be determined are: Cmax, Tmax, AUC0-t, AUC0-inf, TMR, Ke, T1 / 2 of glimepiride and metformin. The statistical analysis will be descriptive for plasma concentrations with respect to time and the pharmacokinetic parameters of Cmax, Tmax, AUC0-t, AUC0-inf, TMR, Ke, T1/2 of glimepiride and metformin. Adverse events were determined using clinical and laboratory test results throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pharmacokinetic Profile
timeFrame: 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:
measure: Adverse Events
timeFrame: 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
Other outcomes:
Locations:
city: México
country: Mexico
facility: Investigación Farmacológica Y Biofarmaceutica, S.A. de C.V.
Study officials:
affiliation: INVESTIGACIÓN FARMACOLÓGICA Y BIOFARMACEUTICA.
name: Yamanqui Ibañez, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996 Feb 29;334(9):574-9. doi: 10.1056/NEJM199602293340906. No abstract available.
citation: 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.
citation: 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.
citation: 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.