Pharmacokinetic Study Of Ibuprofen Injection (IVIb) In Healthy Adult Subjects

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Single Dose, Crossover Study of the Pharmacokinetics, Safety and Tolerability of Ibuprofen Inejction (IVIb) In Healthy Adult Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: IVIb


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: IVIb<br>* 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<br>|
| Active Comparator: 2<br> | Drug: IVIb<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes. |  | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of a single dose of IVIb in healthy adult participants. |  | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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To evaluate the Pharmacokinetic Profile of IVIb