Clinical pharmacology in drug development
Dec 29, 2017
Cardiovascular morbidity is closely associated with serum lipid level. We aimed to investigate the effects of different aromatase inhibitors, including letrozole, anastrozole, and exemestane, on the lipid profile of eastern Chinese breast cancer pati...
Clinical pharmacology in drug development
Dec 19, 2017
The safety profile of fingolimod 0.5 mg, approved therapy for relapsing multiple sclerosis, is well established in clinical and real-world studies. As fingolimod is teratogenic in rats, it was considered important to assess the concentrations of fing...
Clinical pharmacology in drug development
Dec 4, 2015
PURPOSE: The purpose of this study was to investigate potential systemic pharmacokinetic interactions between intranasal fluticasone furoate (FF) and levocabastine (LEVO) when delivered simultaneously via a metered atomizing spray pump.
Clinical pharmacology in drug development
Dec 4, 2015
Intravenous belimumab is approved for the treatment of systemic lupus erythematosus; subcutaneous self-administration would enable greater patient access. This study assessed relative bioavailability, tolerability, and safety of 1 subcutaneous dose o...
Clinical pharmacology in drug development
Oct 20, 2015
The pharmacokinetics (PK) of dapagliflozin and metformin administered as fixed-dose combination (FDC) tablets (2.5 mg dapagliflozin/850 mg metformin or 5 mg dapagliflozin/1000 mg metformin) or as separate tablets in healthy subjects were evaluated in...
Clinical pharmacology in drug development
Oct 5, 2015
Insulin lispro 200 U/mL (IL200) is a new strength formulation of insulin lispro (Humalog®, IL100), developed as an option for diabetic patients on higher daily mealtime insulin doses. This phase 1, open-label, 2-sequence, 4-period crossover, randomiz...
Clinical pharmacology in drug development
Aug 24, 2015
Inhaled, long-acting bronchodilators represent a cornerstone of maintenance treatment for chronic obstructive pulmonary disease (COPD). Aclidinium bromide/formoterol fumarate 400/12 μg fixed-dose combination (FDC) has recently been licensed for use i...
Clinical pharmacology in drug development
Jun 8, 2015
BACKGROUND: LY500307 is a highly selective estrogen receptor β (ERβ) agonist, which loses its selectivity at high dose and leads to undesirable suppression of total testosterone (TT) concentration. The objective of the present analysis was to define ...
Clinical pharmacology in drug development
Feb 2, 2015
PURPOSE: Icatibant is a bradykinin-2 receptor antagonist approved to treat acute hereditary angioedema attacks in adults. To-date, no thorough investigation of the clinical pharmacokinetic (PK) parameters of icatibant and its primary metabolites has ...
Clinical pharmacology in drug development
Jan 26, 2015
PURPOSE: Rucaparib is a potent Poly (ADP-ribose) Polymerase (PARP) inhibitor currently under clinical development. The objectives of this analysis were to establish population PK and PK/PD models for rucaparib, and to evaluate the predictability of P...