Effects of multiple doses of albiglutide on the pharmacokinetics, pharmacodynamics, and safety of digoxin, warfarin, or a low-dose oral contraceptive.

Aims: Albiglutide is a glucagon-like peptide-1 analog that is currently under investigation for the treatment of type 2 diabetes mellitus as a once-weekly injection. Three open-label phase 1 studies were conducted in healthy human participants to investigate potential pharmacokinetic (PK) and/or pharmacodynamic (PD) interactions between albiglutide and medications that may be used concomitantly.

Methods: Digoxin 0.

Summary of Pharmacokinetics and Tissue Distribution of a Broad-Spectrum Fluoroquinolone, JNJ-Q2.

This article summarizes key pharmacokinetic properties of JNJ-Q2, a broad-spectrum fluoroquinolone, being developed for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Two randomized placebo-controlled studies and one open-label study are presented: single and multiple ascending-dose studies evaluating intravenous (IV) and oral pharmacokinetics, absolute bioavailability accumulation, and lung penetration. Fifty-seven participants received JNJ-Q2, which was safe and well tolerated.

Pharmacokinetic modeling and simulation of gastrointestinal transit effects on plasma concentrations of drugs from mixed immediate-release and enteric-coated pellet formulations.

Effects of gastrointestinal transit on plasma concentrations of drugs from mixed immediate-release and enteric-coated pellet formulation were simulated with models developed by including gastric emptying time and lag time of emptying. Models were evaluated by comparing simulated plasma concentrations of amphetamine from Monte Carlo simulations to available published data of a commercial mixed pellet formulation (Adderall XR). Results show that the plasma profile from the mixed pellet formulation does not mimic that from two immediate-release doses administered at different times.