Comparison of 3 cough formulations in Healthy Volunteers V1

• Research type

  Research Study

• Full title

  A Three Way Crossover, Randomised, Single Dose Pilot Bioavailability Study of Levodropropizine New Suspension (LDP/Resin 1/3.33 w/w) and Levodropropizine New Suspension (LDP/Resin 1/5 w/w) Formulations Administered at the Dose of 90 mg versus Levotuss® 30 mg/5 mL Syrup Administered at the Dose of 60 mg to Healthy Volunteers of Both Sexes

• IRAS ID

  53075

• Contact name

  Simon L Singer

• Sponsor organisation

  Dompé s.p.a.

• Eudract number

  2010-019848-39

• ISRCTN Number

  NA

• Research summary

  This study is to compare the two new liquid formulations of modified release LDP with the marketed syrup (Levotuss© 30 mg/5 mL syrup), and assess their safety and tolerability.Subjects will attend a screening visit within 15 days prior to Day 1. Following screening, subjects will be admitted to the Clinical Unit on Day -1 for each of the three study periods, and will remain resident until 10 hours post-dose for completion of study procedures and PK blood sampling on Day 1. There will be a washout-period of at least 3 days (but no more than 6 days) between each study period. Follow-up assessments will be performed prior to discharge in the third and final study period.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC03/12

• Date of REC Opinion

  11 May 2010

• REC opinion

  Further Information Favourable Opinion