Relative Bioavailability study comparing SUBAitraconazole and Sporanox

• Research type

  Research Study

• Full title

  A randomised, open-label, two-treatment, four-period, two-sequence, replicate-design, crossover, bioequivalence study comparing single oral doses of SUBA®-itraconazole 50 mg capsules (Mayne Pharma International Pty Ltd, Australia) with Sporanox® (itraconazole) 100 mg capsules (Janssen-Cilag Ltd, UK) , in healthy adult male and female subjects, under fed conditions

• IRAS ID

  63394

• Contact name

  Ashley Brooks

• Sponsor organisation

  HalcyGen Pharmaceuticals

• Eudract number

  2010-022963-36

• Research summary

  HalcyGen Pharmaceuticals has developed a new formulation of Itraconozole capsules, SUBA© Itraconazole to overcome some of the limitations associated with Sporanox© Capsules. SUBA©-Itraconazole oral formulation of itraconazole has significantly increased solubility at a higher pH and overall bioavailability as compared to Sporonox© Capsules. As a result, the quantity of itraconazole in SUBA©-itraconazole is half that in the Sporonox© Capsules. HalcyGen is seeking approval for its half-dose (50mg) itraconazole capsule which can be taken in the fed state and provides patients with less variable drug levels in the blood compared to Sporonox© Capsules.This study takes place over four periods. Subjects will be assigned to one of two treatment sequences and in each treatment period subjects will receive one of the following treatments: A: SUBA©-itraconazole (itraconazole) capsules, 50 mg under fed conditions B: Sporanox© (itraconazole) capsules, 100 mg under fed conditionsEach subject will receive Treatment A in two Treatment Periods and Treatment B in two Treatment Periods, 30 minutes after starting a high fat breakfast. Each treatment will be administered with 240 mL water and subjects will fast for 4 hours after dose administration.Each subject will participate in four treatment periods, residing at the Clinical Research Unit (CRU) from Day ??1 (the day before dosing) to Day 3 (48 hours post-dose). Subjects will then return for an outpatient visit on Days 4, 5 and 6 (72, 96 and 120 hours post-dose).There will be a minimum of 14 days between each dose administration. Subjects will have post-study visit assessments performed at their Day 6 visit in Treatment Period 4. The expected duration of subject participation is approximately 11 weeks.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC07/24

• Date of REC Opinion

  1 Nov 2010

• REC opinion

  Further Information Favourable Opinion