PK Study for Combination Asthma Inhalers 320/9 mcg and 400/12 mcg

• Research type

  Research Study

• Full title

  An open-label, randomized, four-period crossover, replicate treatment, single-dose study to compare the pharmacokinetic profiles following two inhalations of Budesonide/ Formoterol Spiromax® 320/9 mcg Inhalation Powder and Symbicort® Turbohaler® 400/12 mcg administered in healthy volunteers EudraCT Number: 2010-021656-25

• IRAS ID

  63873

• Contact name

  Muna Albyaty

• Eudract number

  2010-021656-25

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Asthma is a chronic disorder in which the lung's airways become inflamed and breathing becomes difficult. Previous human studies show that the drug under investigation (Budesonide/Formoterol Spiromax© inhalation powder) and a comparable drug (Symbicort©) on the market have similar responses to exposure and adverse events. In this study, the pharmacokinetic profiles of single doses of Budesonide/Formoterol Spiromax© and Symbicort© will be investigated.The study will be performed in different parts and approximately 72 healthy male and female participants will be enrolled. Certain criteria will be applied in order to reach valid conclusions for the study objective. The study will be performed at the PAREXEL Early Phase Clinical Unit, Northwick Park Hospital, Harrow. The study medication will be administered to the participants as an oral inhalation powder. Participants will receive six single administrations (of two inhalations) of the study medication, two in the training period and one in each of the four treatment periods. Participants will undergo the following procedures during the study: medical and medication history; physical examination; height and weight; electrocardiogram (ECG); vital signs (blood pressure, pulse rate and temperature); urine and blood safety tests; and blood samples for the measurement of study drug concentration. Any adverse events that participants experience and other medication that they take will be recorded.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/25

• Date of REC Opinion

  30 Sep 2010

• REC opinion

  Further Information Favourable Opinion