Pharmacokinetic Study Of Ibuprofen Injection (IVIb) In He... | NCT00867880

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

NCT00867880

Sponsor

Cumberland Pharmaceuticals

Status

Completed

Last Update Posted

Dec 15, 2014Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Healthy

Interventions

IVIb

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

May 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Mar 23, 2009

First Submission Date that Met QC Criteria

Mar 23, 2009

First Posted Date

Mar 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2014

Last Update Posted Date

Dec 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: IVIb
2	Active Comparator		Drug: IVIb

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IVIb	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

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

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided