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

NCT00867880 | Completed Phase 1 DMC

• 1 other identifier: CPI-CL-011
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

To evaluate the Pharmacokinetic Profile of IVIb

Outcome Measures

Primary Outcomes (1)

• To evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes.

  12 hours

Secondary Outcomes (1)

• To evaluate the safety and tolerability of a single dose of IVIb in healthy adult participants.

  12 hours

Study Arms (2)

1

EXPERIMENTAL

Drug: IVIb

2

ACTIVE COMPARATOR

Drug: IVIb

Interventions

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

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers between the ages of 18 and 65 years (at the time of consent).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (1)

Centre for Pharmaceutical Research

Underdale, South Australia, 5032, Australia

Location

Study Officials

• Robert Milne, Associate Professor

  Centre for Pharmaceutical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 24, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 15, 2014

Record last verified: 2014-12

Locations

AU (1)