Bioequivalence of 4 PR formulations with Palladone-SR(QBR115089)

• Research type

  Research Study

• Full title

  An open-label, single-dose, pilot and definitive phase study in healthy subjects to assess the pharmacokinetics of two formulations of a hydromorphone/naloxone prolonged release capsule 4/8 mg, one formulation of a hydromorphone/naloxone prolonged release tablet 4/8 mg and one formulation of a hydromorphone/naloxone prolonged release capsule 8/16 mg and a hydromorphone prolonged release capsule 4 mg (Palladone®-SR) all in a fed and fasted state.

• IRAS ID

  119998

• Contact name

  Sharan Sidhu

• Sponsor organisation

  Mundipharma Research Ltd

• Eudract number

  2012-004871-38

• Research summary

  The study drug is a combination of two drugs, Hydromorphone and Naloxone, and is being developed for the treatment of moderate to severe pain. Both Hydromorphone and naloxone are licensed drugs. Hydromorphone is usually used to treat severe pain in cancer patients but it can cause unwanted side effects such as constipation. Naloxone is a drug which will counteract some of the effects of Hydromorphone and can help to reduce constipation. By combining these drugs, it is hoped that the treatment will provide effective pain relief while preventing, or minimising, the occurrence of constipation. The purpose of this study is to investigate how four different oral (taken by mouth) formulations of the study drug are taken up by the body into the bloodstream compared to a reference drug. The reference drug (Palladone©-SR) contains 4 mg of Hydromorphone and is a licensed drug used to treat severe pain in patients with cancer. Three of the products being tested each contain the same amount of drug (Hydromorphone 4 mg and naloxone 8 mg) but differ slightly in their formulation (the way that they are made) so that they will be absorbed into the body at slightly different rates. Two of these formulations will be taken as a capsule and one of these formulations will be taken as a tablet. One product being tested will contain Hydromorphone 8 mg and Naloxone 16 mg and will be taken as a capsule. As this is a healthy volunteer study, Naltrexone is being co-administered to reduce opioid-related side effects. A dosing regimen of naltrexone 50 mg, at - 13 h, -1 h, and h, relative to study drug dosing will be administered. The aim of this study is to find the formulation of the study drug that is absorbed in the most similar way to Palladone©-SR.

• REC name

  HSC REC A

• REC reference

  12/NI/0188

• Date of REC Opinion

  10 Jan 2013

• REC opinion

  Further Information Favourable Opinion