Renal safety profiles of ibandronate 6 mg infused over 15 and 60 min: a randomized, open-label study

Long-term renal safety profile of ibandronate 6 mg infused over 15 minutes.

BACKGROUND In an earlier study, intravenous (i.v.) ibandronate 6 mg administered every 3-4 weeks had a similarly good renal safety profile whether infused over 15 or 60 min in women with breast cancer and bone metastases. This current study focuses on the renal safety of the extended use of ibandronate. PATIENTS AND METHODS Patients completing the original study could choose to enter a follow...

Efficacy and safety of 40 mg or 60 mg duloxetine in Japanese adults with diabetic neuropathic pain: Results from a randomized, 52‐week, open‐label study

INTRODUCTION To examine the long-term efficacy and safety of duloxetine in the treatment of Japanese patients with diabetic neuropathic pain, we carried out a 52-week, randomized, open-label extension of a 12-week, double-blind, placebo-controlled study. MATERIALS AND METHODS Japanese adults with diabetic neuropathic pain who completed the double-blind study were eligible for this long-term s...

Renal safety of ibandronate.

Despite their efficacy in treating complications associated with metastatic bone disease, there are concerns about the potential nephrotoxicity of certain i.v. bisphosphonates for the long-term management of cancer patients. Clinical data suggest, however, that i.v. ibandronate (Bondronat); F. Hoffman-La Roche Ltd., Basel, Switzerland, http://www.roche.com), unlike other bisphosphonates, has a ...

An open-label, randomized, cross-over bioequivalence study of montelukast 10 mg tablets in healthy Thai volunteers

To determine bioequivalence of a generic 10 mg montelukast tablet formulation. A 2-period, 2sequence crossover study was designed. It included 28 healthy subjects, each subject received a single dose of the randomly assigned formulation with 240 ml water after 10-hr fasting, and 14 blood samples (6 mL each) were drawn at predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 10, 12 and 24 hr pos...

Efficacy and Safety of Aripiprazole for Treatment of Irritability in Children with Autistic Disorder: An Open-Label Study