Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Iroko Pharmaceuticals, LLC
Age
6–16
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Body weight ≥18 kilograms.
Mild to moderate acute pain requiring treatment with analgesic medication.
Willing to have blood samples taken for PK sampling using an indwelling catheter.
Must be able to swallow capsules and can tolerate oral medication.
For females: is not of reproductive potential (defined as premenarchal) or is practicing an acceptable method of birth control
You may not be if
Severe acute pain
Chronic analgesic or glucocorticoid use for any condition within 6 months before dosing with study drug.
Emergency surgery
History of allergic reaction, hypersensitivity, or clinically significant intolerance to diclofenac, aspirin, codeine, acetaminophen, or any NSAID
History of peptic ulcer disease or a GI event (eg, perforation, obstruction, or bleed) within 6 months before screening
Current use of any medication that may cause a clinically significant drug interaction when co-administered with diclofenac
Current use of any medication that might affect the pharmacokinetics of diclofenac
History of bleeding disorders .
Developmental delay or behavioral problems that would make it difficult to assess pain.
Impaired liver function
Clinically significant renal or cardiovascular disease
Any medical condition that compromises ability to swallow, absorb, metabolize, or excrete the study drug
Previously received any investigational product or device within 30 days before Screening or scheduled to receive an investigational device or another investigational drug (other than that in this study) during the course of this study.
Previous participation in this clinical study or currently taking diclofenac.
