Pharmacokinetics and bioequivalence study of ranitidine film tablets in healthy male subjects.

The aim of the present study was to compare the bioavailability of ranitidine (CAS 66357-35-5) from two different ranitidine hydrochloride (CAS 66357-59-3) film tablets (Ranitab 150 mg film tablets as test preparation and 150 mg film tablets of the originator product as reference preparation). The study was conducted according to an open-label, randomised two-period cross-over design with a wash-out phase of 9 days. Blood samples for pharmacokinetic profiling were taken up to 24 h post-dose, and ranitidine plasma concentrations were determined with a validated HPLC method with UV-detection.

Bioavailability investigation of two different oral formulations of citalopram, a so-called 'second generation' antidepressant drug.

Citalopram (CAS 59729-33-8) belongs to the so-called 'second generation' antidepressant drugs and is used for the treatment of patients with major depression or other depressive disorders. In the present study, two different oral citalopram formulations (Citalopram-ratiopharm film-coated tablets as test preparation and tablets of a reference preparation distributed in Germany) were investigated in 20 healthy volunteers in order to prove bioequivalence between both preparations. A single 40 mg oral dose was administered according to an open, randomised, two-period cross-over design in the fasted state.

Bioavailability investigation of two different oral formulations of methylprednisolone.

Two different oral methylprednisolone (CAS 83-43-2) formulations (Methylprednisolon-ratiopharm 8 mg tables as test preparation (T) and tablets of a reference preparation (R)) were investigated in 16 healthy volunteers in order to prove bioequivalence between these preparations. A single 8 mg oral dose was given according to a randomised two-way crossover design in the fasted state. Blood samples for determination of methylprednisolone plasma concentrations were collected at pre-defined time points up to 16 h following drug administration.

Transsynovial kinetics of lonazolac and its hydroxy metabolite in synovitis patients.

Objective: The study was designed to characterize the synovial distribution profiles and kinetics of the non-steroidal antiinflammatory agent, lonazolac, in patients with synovitis after multiple dosing with 300 mg tablets of lonazolac calcium salt.

Methods: Forty patients (36 male, 4 female) aged 21 to 50 years (mean: 38+/-9 years) undergoing arthroscopy of the knee joint for surgical reasons were given 7 total doses of drug administered as 300 mg oral tablets of lonazolac-calcium taken twice daily. Patients were assigned to one of 4 treatment groups (n = 10) in which arthroscopy was carried out 1, 2, 6, or 12 h after the seventh lonazolac dose.

Bioequivalence evaluation of two flutamide preparations in healthy female subjects.

In the present study two different preparations containing 250 mg flutamide (3'-trifluoromethyl-4'-nitro-2-methyl-propionylanilide, CAS 13311-84-7) were compared in 20 female subjects. The trial was performed in a randomized two-way cross-over design. Each subject received one tablet with 250 mg flutamide in each period.