None listed
Conditions
Brief summary
This research study is being conducted for the pharmaceutical company Cumberland Pharmaceuticals Inc. You are being asked to take part in this research study because we want to determine the safety, tolerability and pharmacokinetics (the way the body absorbs the drug) of a single dose of ibuprofen administered intravenously (in the vein) over 5-7 minutes. A screening procedure will determine if you are eligible to enter the study. If you are accepted, you will be required to attend the study centre for 2 treatment visits. When you return to the research center, you will be randomised into one of two treatment sequences. Randomised means you will be assigned to a group by chance. The two treatment sequences in this study are: Sequence A: A single dose of intravenous ibuprofen (IVIb) and an oral (capsule) placebo (starch filled capsule) given concurrently on Day 1 of the Treatment Period followed by a single dose of oral ibuprofen (capsule) and intravenous (IV) placebo (saline solution) given concurrently on Day 8 of the Treatment Period. Day 2-7will be a washout period. During the washout period no study drugs or study tests will be done. Sequence B: A single dose of oral ibuprofen and intravenous (IV) placebo given concurrently on Day 1 of the Treatment Period followed by a single dose of intravenous ibuprofen (IVIb) and oral placebo given concurrently on Day 8 of the Treatment Period. Blood samples will be collected in treatment visits 1 and 2 (16 samples per visit) by either cannula (small plastic tube inserted into a vein in your arm) or venipuncture. Approximately a total of 222 mL of blood will be collected during the study, which includes the amount required for the clinical laboratory tests and for the measurement of Ibuprofen in your blood.
Interventions
1) Single dose of IVIb and Oral Placebo
1a)Single dose of active intravenous 8mL of ibuprofen in a 192mL bag of saline and Single dose of placebo oral 800mg sugar pill
2) Single dose of Oral Ibuprofen and intravenous placebo
2a) Single dose of active oral 800mg ibuprofen and Single dose of placebo intravenous 200mL of saline
Oral and Infusion to be taken concurrently over 5-7 minutes.
Sponsors
Cumberland Pharmaceuticals Incorparated
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
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 Non-Steroidal Anti-Inflammatory Drugs (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.
Outcome results
None listed