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

NCT ID: NCT00867880

Last Updated: 2014-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-06-30

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.

Detailed Description

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Conditions

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Healthy

Keywords

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To evaluate the Pharmacokinetic Profile of IVIb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type EXPERIMENTAL

IVIb

Intervention Type DRUG

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

2

Group Type ACTIVE_COMPARATOR

IVIb

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Milne, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Centre for Pharmaceutical Research

Locations

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Centre for Pharmaceutical Research

Underdale, South Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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CPI-CL-011

Identifier Type: -

Identifier Source: org_study_id