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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00867880
• Other study ID #: CPI-CL-011
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2009
• Last updated: December 12, 2014
• Start date: March 2009
• Est. completion date: June 2009

Study information

• Verified date: December 2014
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Australia	Centre for Pharmaceutical Research	Underdale	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes.		12 hours	No
Secondary	To evaluate the safety and tolerability of a single dose of IVIb in healthy adult participants.		12 hours	Yes