Effect of NVA237 and cimetidine co-administered in healthy adults

• Research type

  Research Study

• Full title

  A randomized, open label, two-period, crossover study to determine the effect of oral doses of cimetidine on the pharmacokinetics of a single inhaled dose of NVA237 upon co-administration in healthy adult subjects

• IRAS ID

  60989

• Contact name

  Muna Albayaty

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-021267-32

• Research summary

  Chronic Obstructive Pulmonary Disease (COPD) has a significant impact on society causing death and a decrease in quality-of-life. It is a leading cause of death in the western world and is one of the common diseases in developing countries like India and China. Medications, called antimuscarinic agents (the type of drug as the study drug), are used to make breathing easier as treatment of COPD.The study drug, an inhaler, is known by the number NVA237. The other medication, Cimetidine, is used in treating stomach ulcers and is marketed under the name Tagamet©.In this study, the effect that Tagamet© has on the pharmacokinetic profile of NVA237 will be investigated.The study will be performed in two parts and approximately 20 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 follows:An inhaler for NVA237, 100 æg per dose (given as 2 x 50 æg dry powder capsules for inhalation).Tablets for 800 mg Tagamet© per dose (given as 2 x 400 mg tablets), which will be swallowed with a glass of water.Participants will receive NVA237 twice and Tagamet© 12 times.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, blood sample for DNA test, alcohol breath test, and blood and urine samples for the measurement of study drug concentration. Any adverse events that participants experience and other medication they they take will be recorded.

• REC name

  Scotland A REC

• REC reference

  10/IEC02/22

• Date of REC Opinion

  23 Sep 2010

• REC opinion

  Further Information Favourable Opinion