Bioequivalence study of two different clopidogrel bisulfate film-coated tablets.

Objective: The aim of the present study was to evaluate the bioequivalence of two oral clopidogrel (CAS 113665-84-2) formulations.

Method: The study was conducted as a monocentric, open, randomized, single-dose, two-period crossover trial in 48 healthy volunteers with a duration of hospitalization of approximately 24 h after dosing on day 1 and with a real wash-out period of 7 days. Blood samples were collected for 24 h post dosing in each period.

Analysis of pooled plasma samples as a predictor for proving bioequivalence of drugs with a long elimination half-life. The example of phenprocoumon.

The results of pooled plasma analysis in a bioequivalence trial provide information comparable with that of the mean concentration vs. time curves for each formulation. Although it seems feasible that pool plasma analysis will have similar or even greater advantages in cases of bioequivalence trials with a parallel-group design, no such data has been published in the literature probably due to the limited number of such trials.

Serotonin reuptake inhibitors: bioequivalence of sertraline capsules.

The study was designed to evaluate the bioavailability of two sertraline (CAS 79617-96-2) formulations. A bioequivalence study was carried out in 24 healthy male volunteers, who were administered 50 mg capsules of the test formulation (Seralin) and the originator product (reference) as a single dose. The trial was performed according to an open, randomized, cross-over design with a washout period of 14-20 days in one study center.

Bioequivalence study of rofecoxib tablets.

The study was designed to evaluate the bioavailability of two rofecoxib (CAS 162011-90-7) tablet formulations. Twenty-four healthy male volunteers were administered a 25 mg tablet of the test formulation (Ecrox) containing rofecoxib or the originator product (reference). The trial was performed according to an open, cross-over design with a wash-out period of 7 days.

Combination of losartan and hydrochlorothiazide: in vivo bioequivalence.

Two trials were performed in different groups of volunteers with the aim to compare the bioavailability of 50 mg losartan tablets (Sarvas as test and an originator product as reference formulation; study 1) and losartan/hydrochlorothiazide (50 mg/12.5 mg) (CAS 124750-99-8/CAS 58-93-5) combined formulations (Sarvastan as test and an originator product as reference formulation; study 2), respectively. Each study was conducted according to an open, randomized, single-dose, two-period cross-over design in 24 healthy volunteers with a wash-out period from 7 to 14 days.

Effect of the combination of lisinopril and hydrochlorothiazide on the bioequivalence of tablet formulations.

The aim of the present studies, performed in two different groups of volunteers, was to compare the bioavailability of 20 mg lisinopril tablets (Sinopryl as test and an orignator product as reference formulation; study 1) and lisinopril/hydrochlorothiazide (20 mg/12.5 mg) (CAS 83915-83-7/CAS 58-93-5) combined formulations (Sinoretik as test and an originator product as reference formulation; study 2). Each study was conducted according to an open, randomized, single-dose, two-period cross-over design in healthy volunteers with a wash-out period from 7 to 14 days.

Clarithromycin suspension: bioequivalence studies on two different strengths.

Two studies were performed in different groups of volunteers, with the aim to prove the bioequivalence of test (Klaromin) and reference clarithromycin (CAS 81103-11-9) suspensions containing in 5 mL either 125 mg (study 1) or 250 mg (study 2) of the drug, administered as an oral dose of 10 mL. Each study was conducted according to an open, randomized, single-dose, two-period cross-over design in healthy volunteers with a wash-out period from 7 to 14 days. Blood samples were taken up to 24 h in both studies, and concentrations of clarithromycin and its principal active 14-hydroxy metabolite were determined by HPLC.

Studies on the bioequivalence of different strengths of tablets containing clarithromycin.

The aim of the present studies, performed in two different groups of volunteers, was to compare the bioavailability of clarithromycin (CAS 81103-11-9) tablets (Klaromin, test tablets) containing 250 mg (study 1) or 500 mg (study 2) of the drug with reference tablets of the same strength. Each study was conducted according to an open, randomized, single-dose, two-period crossover design in healthy volunteers with a wash-out period from 7 to 14 days. Blood samples were taken up to 24 h in both studies, and concentrations of clarithromycin and its principal active 14-hydroxy metabolite were determined by HPLC method.

Assessment of the bioequivalence of different formulations containing azithromycin (tablets and suspension).

Azithromycin (CAS 11772-70-0) is an orally administered macrolide antimicrobial drug, structurally related to erythromycin, with a similar spectrum of antimicrobial activity. The aim of the present studies, performed in two different groups of volunteers, was to compare the bioavailability of azithromycin (Azro) 500 mg tablets (study 1) and azithromycin (Azro) 200 mg/5 mL suspensions (study 2) with originator products. Each study was conducted according to an open, randomized, single-dose, two-period cross-over design in 24 healthy volunteers with a wash-out period from 14 to 21 days.

Bioequivalence study of atorvastatin tablets.

The study was designed to evaluate the relative bioavailability of two formulations of atorvastatin (CAS 134523-03-8). A bioequivalence study was carried out in 24 healthy male volunteers who received four 10 mg tablets of the test formulation (Kolestor) and the same dose of the originator product. The trial was performed according to an open, crossover design with a wash-out period of 7 days in one study center.

Clinical relevance of bioequivalence acceptance criteria. The example of terbinafine.

Objective: The present study was conducted with the aim of investigating which acceptance criteria for bioequivalence are relevant for orally applied antimycotics using terbinafine (CAS 78628-80-5) as an example.

Methods: A bioequivalence trial was performed in 18 healthy male volunteers with the aim of comparing a new generic product (tablets containing terbinafine hydrochloride, equivalent to 250 mg base) with the originator product. The trial was performed according to an open, cross-over design in one study centre.