Bioequivalence of rusovastatin in healthy human volunteers was done using saliva and plasma matrices in order to investigate the robustness of using saliva instead of plasma as a surrogate for bioequivalence of class III drugs according to the salivary excretion classification system (SECS). Saliva and plasma samples were collected for 72 h after oral administration of rusovastatin 40 mg to 12 ...

The bioequivalence of the diminazene formulation Veriben (Centaur) was determined in cattle (n = 10) by means of a single-dose, randomized cross-over experiment. The results of nine statistical procedures commonly used for bioequivalence evaluation are discussed. Veriben was found to be equivalent to Berenil (Hoechst) with respect to the area under the plasma concentration versus time curve, bu...

A bioequivalence study of two oral formulations of 500 mg cefuroxime axetil was carried out in 24 healthy volunteers following a single dose, standard two-treatment cross-over design at the College of Pharmacy, King Saud University, Riyadh, Saudi Arabia, working jointly with King Khalid University Hospital. The two formulations used were Cefuzime (Julphar, United Arab Emirates) as the test and ...

PURPOSE The primary aim of the present study was to assess the pharmacokinetic bioequivalence between a generic formulation of meloxicam 15 mg tablets (Meloxicam Hexal) and its respective brand product (Mobic), in order to verify whether the generic product conforms to the regulatory standards of bioequivalence in the postmarketing setting. As a secondary exploratory aim, the pharmacodynamic ef...

Article history: Received on: 21/03/2016 Revised on: 11/06/2016 Accepted on: 17/07/2016 Available online: 26/09/2016 The objective of the present study was to compare and evaluate the economic benefits and in-vitro bioequivalence of different marketed generic ciprofloxacin tablets against the innovator tablet formulation that are present in the local market of Saudi Arabia. The comparative bioe...

WHAT IS KNOWN AND OBJECTIVE There is great interindividual variability in citalopram (CIT) pharmacokinetics. We attempted to establish a population pharmacokinetic (PPK) model of CIT in Chinese healthy subjects, to evaluate the effect of genetic polymorphism on CIT pharmacokinetics and to compare the PPK and non-compartmental (NCA) assays in the estimation of CIT bioequivalence. METHODS Blood...

The effect of semaglutide, a once-weekly human glucagon-like peptide-1 (GLP-1) analog in development for type 2 diabetes (T2D), on the bioavailability of a combined oral contraceptive was investigated. Postmenopausal women with T2D (n = 43) on diet/exercise ± metformin received ethinylestradiol (0.03 mg)/levonorgestrel (0.15 mg) once daily for 8 days before (semaglutide-free) and during (steady...

OBJECTIVE The aim of this study was to evaluate the bioequivalence of two drug products, generic clopidogrel bisulfate 75 mg film-coated tablets versus the reference Plavix(®) clopidogrel bisulfate 75 mg film-coated tablets. METHODS Bioequivalence of tablets was tested by comparisons against the reference brand product in accordance with the requirements of the Declaration of Helsinki, the cu...

Abstact To determine the bioequivalence of two formulations of recombinant human erythropoietin alpha (epoetin alpha 4000-IU), the two formulations; Renogen® and the Reference, Eprex® were administered to 18 healthy Thai male volunteers as a single subcutaneous dose according to a randomized two-way crossover design. Serial blood samples were collected over a period of 96 hours. The pharmacokin...