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

This study has been completed.

Sponsor:

Information provided by:

Cumberland Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00867880

First received: March 23, 2009

Last updated: July 9, 2009

Last verified: July 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 23, 2009

Last Updated Date

July 9, 2009

Start Date ^ICMJE

March 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00867880 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the safety and tolerability of a single dose of IVIb in healthy adult participants. [ Time Frame: 12 hours ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
Intervention: Drug: IVIb
Active Comparator: 2
Intervention: Drug: IVIb

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00867880

Other Study ID Numbers ^ICMJE

CPI-CL-011

Has Data Monitoring Committee

Yes

Responsible Party

Amy Rock, PhD., Senior Manager, Regulatory Affairs, Cumberland Pharmaceuticals Inc.

Study Sponsor ^ICMJE

Cumberland Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Robert Milne, Associate Professor

Centre for Pharmaceutical Research

Information Provided By

Cumberland Pharmaceuticals

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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