Mike John van der Meer

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A randomised cross-over study in 24 postmenopausal women was selected to establish bioequivalence of two tamoxifen (CAS 10540-29-1) formulations. In addition, this study compiled pharmacokinetic parameters for the current 30 mg regimen in postmenopausal women, the target population of tamoxifen therapy. Mean Cmax values of 59.1 +/- 8.9 (T) and 63.6 +/0 11.1(More)
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(More)
Urine specimens of 8 organophosphate-poisoned patients on treatment with large doses of atropine were screened for atropine metabolites using thin-layer chromatography. Only atropine was detected. High performance liquid chromatography of urine specimens of a poisoned patient receiving large doses of atropine likewise detected only 3H-atropine after(More)
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(More)
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,(More)
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(More)
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,(More)
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(More)