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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: IVIb

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Underdale, South Australia, Australia, 5032
      • Centre for Pharmaceutical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: IVIb; 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
Active Comparator: 2	Drug: IVIb; 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cumberland Pharmaceuticals
• Investigators: Principal Investigator: Robert Milne, Associate Professor, Centre for Pharmaceutical Research

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: March 23, 2009
• First Submitted That Met QC Criteria: March 23, 2009
• First Posted (Estimate): March 24, 2009

Study Record Updates

• Last Update Posted (Estimate): December 15, 2014
• Last Update Submitted That Met QC Criteria: December 12, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: To evaluate the Pharmacokinetic Profile of IVIb
• Other Study ID Numbers: CPI-CL-011