Prolonged release pirfenidone pharmacokinetics is modified in cirrhosis GENESIS study.

Background: In both clinical and experimental trials, pirfenidone (PFD) showed anti-inflammatory and antifibrogenic effects. Considering the wide variation in hepatic functional reserve in patients with cirrhosis, we decided to learn more about the pharmacokinetics of a new formulation of prolonged release PFD in this population (PR-PFD), focusing on assessing changes on AUC, AUC, and C.

Methods: In this study, 24 subjects with cirrhosis were included: eight subjects with mild liver impairment (Child-Pugh A) and eight with moderate liver impairment (Child-Pugh B), and a third group of eight age-matched subjects without fibrosis.

Bioequivalence Assessment of an Oral Fixed-Dose Formulation of Dutasteride-Tamsulosin 0.5 mg/0.4 mg: A Randomized, Single-Blind, Single-Dose, 2-Period Crossover Study in Mexican Population Under Fasted Conditions.

The aim of the present study was to compare the bioavailability and to demonstrate the bioequivalence between a dutasteride-tamsulosin 0.5 mg/0.4 mg capsule formulation and the regulatory reference drug (Combodart®, GlaxoSmithKline).

Bioavailability assessment of fexofenadine and montelukast in a fixed-dose combination tablet the components administered simultaneously.

Introduction And Objectives: Allergic rhinitis is a condition with high global prevalence most effectively treated with antihistamines and antileukotrienes. This study aimed to evaluate the bioequivalence of fexofenadine and montelukast in a fixed-dose combination tablet versus the components administered simultaneously.

Materials And Methods: An open, randomized, 2×2 crossover study was performed in 78 healthy volunteers.

Pharmacogenetics of amfepramone in healthy Mexican subjects reveals potential markers for tailoring pharmacotherapy of obesity: results of a randomised trial.

Amfepramone (AFP) is an appetite-suppressant drug used in the treatment of obesity. Nonetheless, studies on interindividual pharmacokinetic variability and its association with genetic variants are limited. We employed a pharmacokinetic and pharmacogenetic approach to determine possible metabolic phenotypes of AFP and identify genetic markers that could affect the pharmacokinetic variability in a Mexican population.

A pharmacogenetic pilot study reveals MTHFR, DRD3, and MDR1 polymorphisms as biomarker candidates for slow atorvastatin metabolizers.

Background: The genetic variation underlying atorvastatin (ATV) pharmacokinetics was evaluated in a Mexican population. Aims of this study were: 1) to reveal the frequency of 87 polymorphisms in 36 genes related to drug metabolism in healthy Mexican volunteers, 2) to evaluate the impact of these polymorphisms on ATV pharmacokinetics, 3) to classify the ATV metabolic phenotypes of healthy volunteers, and 4) to investigate a possible association between genotypes and metabolizer phenotypes.

Methods: A pharmacokinetic study of ATV (single 80-mg dose) was conducted in 60 healthy male volunteers.

Application of Genomic Technologies in Clinical Pharmacology Research.

Technology is the basis of scientific progress and is an essential component for continued competitiveness in industry. The development of a new drug candidate is a long and expensive process, in which a molecule undergoes several stages of research (both pre-clinical and clinical) before being approved for commercialization. Scientific progress has revolutionized the pharmaceutical industry and reshaped the processes by which new drugs are discovered, investigated, and developed.

Isotretinoin conundrum: a randomized, openlabel, crossover study in Mexico to evaluate the bioavailability and bioequivalence of three pharmaceutical preparations of isotretinoin in healthy participants.

Objective: The oral retinoid agent isotretinoin (13-cis-retinoic acid) is approved for the treatment of severe recalcitrant cystic acne. For registrational renewal of Oratane® in Mexico (isotretinoin; Laboratorios Dermatologicos Darier S.A.

Bioequivalence of single 100-mg doses of two oral formulations of topiramate: an open-label, randomized-sequence, two-period crossover study in healthy adult male Mexican volunteers.

Background: The proprietary form of topiramate is indicated in Mexico as an antiepileptic agent and in the prophylaxis of migraine headaches. However, before generic topiramate is placed on the market, pharmacokinetic studies investigating the bioequivalence of generic and branded formulations are needed.

Objective: The aim of this study was to compare the bioequivalence and tolerability of a generic (test) and a branded (reference) formulation of topiramate 100 mg in healthy Mexican volunteers.

Evaluation of the bioequivalence of single 100-mg doses of two oral formulations of cyclosporin A microemulsion: a randomized, open-label, two-period crossover study in healthy adult male Mexican volunteers.

Background: Cyclosporin A is widely used in Mexico as immunosuppressive therapy in organ transplantation and in the treatment of autoimmune disorders. Although several generic oral formulations of cyclosporin A are available in Mexico, information concerning the bioequivalence of these formulations in the Mexican population is not available in the published literature.

Objective: The aim of this study was to compare the bioequivalence and tolerability of a generic (test) and a branded (reference) soft-gelatin capsule formulation of cyclosporin A microemulsion 100 mg available in Mexico.

Bioavailability of two oral formulations of loratadine 20 mg with concomitant ketoconazole: an open-label, randomized, two-period crossover comparison in healthy Mexican adult volunteers.

Background: Loratadine is a long-acting antihistamine with selective peripheral histamine H(1)-receptor antagonistic activity and fewer sedative effects compared with conventional antihistamines, and is widely used in Mexico. Although several generic formulations of loratadine are available in Mexico, based on a literature search, information concerning the bioavailability of each formulation in the Mexican population is not available.

Objective: The aim of this study was to compare the bioavailability and tolerability of 2 oral formulations of loratadine 20 mg (two 10-mg tablets) used in Mexico: Sensibit (test formulation; Laboratorios Liomont S.

Bioavailability of two oral formulations of azithromycin 500 mg: a randomized, open-label, two-period crossover comparison in healthy Mexican adult subjects.

Background: Azithromycin is related to erythromycin but is more active against gram-negative bacteria and less active against streptococci and staphylococci compared with erythromycin. For these reasons, and because of convenience of dosing (QD for 3 days), azithromycin is widely used in Mexico. Although several generic formulations of azithromycin are available in Mexico, information concerning the bioavailability of each formulation in the Mexican population is not available.