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Pharmacokinetics, Safety, and Tolerability of BAY 12–9566 and Nonsteroidal Anti‐inflammatory Agents (Naproxen, Ibuprofen) during Coadministration in Patients with Osteoarthritis
Author(s) -
Shah Anita,
Woodruff Marilyn,
Agarwal Vipin,
Liu Patrick,
Sundaresan Pavur
Publication year - 2001
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/00912700122010032
Subject(s) - naproxen , pharmacokinetics , tolerability , ibuprofen , medicine , bay , osteoarthritis , pharmacology , nonsteroidal , placebo , analgesic , drug , adverse effect , civil engineering , alternative medicine , pathology , engineering
The pharmacokinetic interactions between BAY 12–9566 and two nonsteroidal anti‐inflammatory drugs (NSAIDs), naproxen and ibuprofen, were investigated in osteoarthritis (OA) patients. The study comprised six groups: two NSAID groups with three levels of treatment (BAY 12–9566 400 mg, BAY 12–9566 100 mg, and placebo). Plasma pharmacokinetic parameters (AUCτ’ C max’ , and t max ) were determined for each treatment group following 5 days of NSAID administration, 14 days of BAY 12–9566 administration, and 14 days of concurrent NSAID and BAY 12–9566 administration. For most conditions, the total plasma drug concentrations of both NSAID and BAY 12–9566 were diminished by coadministration; total plasma BAY 12–9566 was not affected by ibuprofen treatment. Importantly, the free drug concentrations were largely unaffected by coadministration. Most side effects were mild or moderate in intensity, and all events, with the exception of headache, were reported in both NSAID groups and in both placebo and BAY 12–9566 groups.