82791
document
Absolute bioavailability of a new high dose methylprednisolone tablet formulation . This was a single-blind , single-dose , randomized crossover study to determine the absolute bioavailability of Medrol , a new high dose ( 100 mg ) methylprednisolone tablet product , by comparing it with 100 mg methylprednisolone from an intravenous formulation , Solu-Medrol . Fourteen healthy , non-smoking , Caucasian male volunteers took part . On treatment days volunteers remained recumbent for 4 hours after drug administration , with food and fluid intake standardized over this period . Serial blood samples were drawn over a 14-hour period after drug administration . Plasma methylprednisolone concentrations were determined by high performance liquid chromatography . The geometric means of AUCi.v . and AUCtablet were 4,049 and 3,334 ng.h/ml , respectively . The absolute bioavailability of the tablet product was 82 % , which is in agreement with published data for other oral dosage forms of methylprednisolone . Volunteers displayed the expected rise in peripheral blood neutrophil count , but no other clinically relevant changes in hematology or clinical chemistry were observed . No adverse drug reactions were recorded . It is concluded that the tablet product can be used as a substitute for parenteral methylprednisolone in situations requiring high-dose therapy .
82792
Intervention_Pharmacological
methylprednisolone
82793
Intervention_Pharmacological
Medrol
82794
Intervention_Pharmacological
methylprednisolone
82795
Intervention_Pharmacological
methylprednisolone
82796
Intervention_Pharmacological
Solu-Medrol
82797
Intervention_Pharmacological
methylprednisolone
82798
Intervention_Pharmacological
methylprednisolone
82799
Intervention_Pharmacological
methylprednisolone
82800
Outcome_Physical
peripheral blood neutrophil count
82801
Participant_Sample-size
Fourteen
82802
Participant_Sex
male