RT Journal Article
SR Electronic
T1 Evaluation of systemic exposure between two nasal spray formulations of mometasone furoate in healthy subjects
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P913
VO 42
IS Suppl 57
A1 Mukul Phatak
A1 Siddharth Chachad
A1 Shrinivas Purandare
A1 Geena Malhotra
A1 Kalindi Gandhi
YR 2013
UL http://erj.ersjournals.com/content/42/Suppl_57/P913.abstract
AB Mometasone furoate (MF) is a topical glucocorticosteroid with local anti-inflammatory properties. This pharmacokinetic study was conducted to evaluate the total systemic exposure of mometasone furoate when administered as nasal spray between the test product (MF aqueous nasal spray suspension 50 mcg/actuation of Cipla Ltd., India) and the reference product (Nasonex, containing MF 50 mcg/actuation of Merck Sharp & Dohme Ltd., UK). In the randomized, open label, crossover study, 48 healthy adult male human subjects received a single dose on two treatment days separated by a washout period of 8 days. The subjects were administered a dose of 400 mcg in each period as 8 puffs (4 puffs in each nostril) under fasting conditions. The plasma samples of 45 subjects completing the study were analyzed and considered for the final pharmacokinetic and statistical evaluations. The 90 % confidence intervals for ratios (%) of the least square mean of the test and reference product of log transformed data for Cmax, AUC0-t and AUC0-inf for MF were 85.61 to 103.17, 96.17 to 115.87 and 94.12 to 112.18 respectively. MF plasma concentration-time profile following administration of the test product was similar to that of the reference product. Hence the two formulations can be concluded to have a similar systemic bioavailability. No serious adverse event was reported during the course of study and both the products were well tolerated after administration of single dose of 400 mcg. In summary, the test product has similar systemic exposure to that of the reference product.