Ibuprofen Formulations (reference) and (test) Bioequivalence study

• Research type

  Research Study

• Full title

  A pivotal, open label, randomised, balanced, two-way crossover bioequivalence study of a single oral dose of 2 x 200 mg Ibuprofen Formulation A (reference) and 2 x 200 mg Ibuprofen Formulation B (test) in healthy, adult, human (male and female) participants under fasting conditions.

• IRAS ID

  1006326

• Contact name

  Alexander von Wilamowitz-Moellendorff

• Sponsor organisation

  Reckitt

• ISRCTN Number

  ISRCTN91129283

• Research summary

  Ibuprofen is a commonly used anti-inflammatory drug. Many companies manufacture and sell Ibuprofen. In this study the sponsor is trying to compare their Ibuprofen formulation (called the Test formulation) with the Ibuprofen formulation made by another company (called the reference formulation). To protect commercial interests the two different Ibuprofen formulations made by two different companies (Catalent and Pantheon) are referred to as Formulation A and B respectively,
  Dose of the Ibuprofen that will be studied in this trial is 2X 200 mg of each formulation. The study drug will be given orally in the fasting state.
  Approximately 28 subjects (Male and female) will be recruited in the study. Each study participant will be screened 28 days in advance of the trial and only those meeting the study inclusion/exclusion criteria will be enrolled. The study will involve two treatment periods - Period 1 and 2. The study participant will receive one type of formulation at a given treatment period and at the next treatment period will receive the other formulation. In effect, each participant would have received the two different Ibuprofen formulations and this type of study design is called a cross-over study design. This allows minimisation or elimination of inter-individual differences in drug absorption and metabolism. The amount of Ibuprofen absorbed will be reflected in the blood concentration of Ibuprofen which is called pharmacokinetics. This will be a major objective of the trial to see how the drug concentration builds up in the blood stream over time after the dosing. Safety of the participants who took the study medications will also be monitored. Frequent blood draws will be carried out to measure drug concentrations as well do safety laboratory tests. There will be a Five-day gap between two treatment periods. All study participants will be provided as much information about the study as possible to enable them to sign the informed consent.

• REC name

  Wales REC 1

• REC reference

  22/WA/0314

• Date of REC Opinion

  6 Dec 2022

• REC opinion

  Further Information Favourable Opinion