Effects of food intake on the pharmacokinetics of diclofenac potassium soft gelatin capsules: a single-dose, randomized, two-way crossover study.

Background: Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC) is an investigational formulation that uses dispersing agents designed to facilitate rapid and consistent absorption of this NSAID.

Objective: The aim of this study was to characterize the effects of food intake on the pharmacokinetic (PK) profile of oral DPSGC at doses of 25 and 50 mg.

Methods: In this open-label, randomized, single-dose (2 distinct doses), 2-way crossover bioavailability study, healthy adult volunteers were randomly assigned to receive a single dose of DPSGC 25 or 50 mg after an overnight fast (fasted condition) or high-fat breakfast (fed condition) (period 1).

Analysis of pharmacokinetic-dynamic interrelations with special reference to applications in cardiovascular clinical pharmacology.

The relationship between a (detectable) cardiovascular response and plasma concentrations is affected by 1. the temporal delay of the equilibrium between sampling site and effector site(s), 2. the intrinsic relationship between the primary effect(s) and concentration at the effector site(s) and 3.

Antihistamine activity and central effects of WAL 801 CL in man.

The tolerability and antihistaminic activity of WAL801 CL, a new, peripherally acting H1-receptor antagonist, have been evaluated in a double-blind, placebo-controlled, within-subject cross-over study. WAL801 CL 8 mg b.d.