Objective: The present study's objective is to conduct a comparative bioavailability study with special emphasis on the test product's bioequivalence using standard reference product as comparator.
 Methods: Before initiating bioequivalent study, plasma sample analysis method was developed and validated by LC-MS/MS method. entire conducted single-dose crossover randomized open-label, two t...

PURPOSE: The primary objective of the studies was to demonstrate bioequivalence between the oral granules formulation and chewable tablet of montelukast in the fasted state. Effect of food on the pharmacokinetics of the oral granules was also evaluated. METHODS: The Formulation Biocomparison Study (Study 1) and the Final Market Image Study (Study 2) each used an open-label, randomized, 3-period...

There is interest in evaluating the efficacy of lower doses of certain antiretrovirals for clinical care. We determined here the bioequivalence of plasma lamivudine (3TC) and intracellular 3TC-triphosphate (3TC-TP) concentrations after the administration of two different doses. ENCORE 2 was a randomized crossover study. Subjects received 3TC at 300 and 150 mg once daily for 10 days (arm 1; n = ...

BACKGROUND Growth hormone (GH) is used to treat growth hormone deficiency (GHD, adult and paediatric), short bowel syndrome in patients on a specialized diet, HIV-associated wasting and, in children, growth failure due to a number of disorders including Turner's syndrome and chronic renal failure, and in children born small for gestational age. Different brands and generic forms of recombinant ...

Background: Metamizole (Dipyrone) is widely used and has effective analgesic, antipyretic, and antispasmodic properties. After oral or intravenous administration, dipyrone is rapidly hydrolyzed to the active moiety 4-methylaminoantipyrine. Aim: The aim of this study was to assess the bioequivalence of 2 oral formulations of Metamizole 500 mg. Methods: This double blind, randomized, single-dose,...

BACKGROUND Easyhaler(®) device-metered dry powder inhaler containing budesonide and formoterol fumarate dihydrate (hereafter formoterol) for the treatment of asthma and chronic obstructive pulmonary disease has been developed. The current approvals of the product in Europe were based on several pharmacokinetic (PK) bioequivalence (BE) studies, and in vitro-in vivo correlation (IVIVC) modeling. ...

The symmetric confidence interval method for bioequivalence testing, proposed by Westlake (1976, 1979), is founded on a premise which is highly questionable, and in his description of the method, Westlake confuses two distinct statistical issues. The purpose of this note is to clarify the apparent flaws in Westlake's method and to point out a formal similarity between testing drugs for bioequiv...

      The pharmacokinetic properties of amoxicillin and clavulanic acid when used alone or in combination may be different and show interaction between these two agents that might decrease the absolute bioavailability of clavulanic acid. In an open, randomized, replicated Latin square under fasting condition, pharmacokinetics of new formulations of amoxicillin/clavulanic acid were compared with...

Two drug products are considered bioequivalent 'if their bio-availabilities ... are similar to such a degree that their effects, with respect to both efficacy and safety, will essentially be the same'. 1 The bioequivalence of two drug products is generally demonstrated through a clinical study in healthy volunteers, the so-called bioequivalence study. If bioequivalence is shown for two drug pro...

Venlafaxine is a unique antidepressant approved for treatment of various depressive disorders. A single dose, cross-over bioequivalence study was performed with two different formulations of venlafaxine 150 mg extended-release capsules in which the contents of capsule were mixed with applesauce and administered to healthy subjects under fed condition. A total of 24 healthy adult male subjects p...