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Completed

NCT Number: NCT00867880

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

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Pharmaceutical Research

Underdale, South Australia, 5032, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: 12 hours

Secondary outcomes

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

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 24, 2009
Registry last updated
Dec 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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