Healthy
Conditions
Keywords
To evaluate the Pharmacokinetic Profile of IVIb
Brief summary
The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes.
Interventions
DRUGIVIb
800mg IVIb diluted in 200mL NS will be given IV (in the vein) concurrently with an oral placebo on Day 1 and 200ml Normal Saline will be given IV (in the vein)concurrently with 800mg oral ibuprofen on Day 8
Sponsors
Cumberland Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers between the ages of 18 and 65 years (at the time of consent).
Exclusion criteria
* Participants lacking good venous access in both arms. * History of allergy or hypersensitivity to NSAIDs or any component of intravenous ibuprofen. * Have never taken aspirin or ibuprofen * History of abuse of alcohol or other drugs in the 2 months before CTM administration. * Have used prescription drugs (not including oral contraceptives) within 14 days before CTM administration or have used aspirin within one week before CTM administration or over-the-counter pain relievers (NSAIDs or acetaminophen) within 3 days before CTM administration. * Have taken investigational drugs within 30 days before CTM administration. * Have donated blood or blood products within 30 days before CTM administration. * Be pregnant or nursing. * Have had breast cancer. * Have a clinically significant laboratory test * Presence or history of the following conditions: asthma, bleeding tendency, hypertension, heart failure, peptic ulcer disease, inflammatory bowel disease, or any other gastrointestinal disorder, renal or hepatic disease.. * Have a calculated creatinine clearance (estimated by means of the Cockcroft-Gault equation) of \< 75mL/min * Inability to understand the requirements of the study. Participants must be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions. * Refusal to provide written authorization for use and disclosure of protected health information * Be otherwise unsuitable for the study, in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes. | 12 hours |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of a single dose of IVIb in healthy adult participants. | 12 hours |
Countries
Australia
Outcome results
None listed