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Wenyuan Qi,1,2 Yue Liu,1,2 Wei Xue,1,2 Kexin Li,1,2 J Christopher Gorski,3 Mark Liu,3 Tieliang Yan,3 Duc Tung Nguyen,4 Rajesh Kumar Ramalingam5 1Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China; 2Assessment of Clinical Drugs Risk and Individual Application Key Laboratory, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China; 3Global Clinical Pharmacology, Mylan Pharmacetical Inc. (Now Viatris), Morgantown, WV, USA; 4Global Clinical Sciences, MEDA Pharma GmbH & Co. KG (A Viatris Company), Bad-Homburg, Germany; 5Global Medical Affairs, Mylan Pharmaceuticals Private Limited (Now Viatris), Bengaluru, IndiaCorrespondence: Kexin Li, Clinical Trial Centre, Beijing Hospital, No. 1 Dahua Road, Dongdan Dongcheng District, Beijing, People’s Republic of China, Email kexinli6202@163.comObjective: Two studies (Study I and Study II) were conducted in healthy Chinese volunteers to confirm that there was no pharmacokinetic drug interaction between AZE and FLU in MP-AzeFlu. The secondary objective was to evaluate the pharmacokinetic parameters of MP-AzeFlu compared with the commercially available mono-components.Methods: Both studies were a randomized, open-label, three-period, six-sequence, single-dose cross-over trial (William’s design) conducted at Beijing Hospital (Beijing, China) in September and October of 2019 in 30 healthy adult male and female volunteers. The natural log transformed parameters: AUC0-tlast, AUC0-∞ and Cmax were analyzed.Results: The comparison of PK parameters between MP-AzeFlu and Aze (commercially available) showed that the LS mean ratios (90% CI) values for, AUC0–tlast, AUC 0–∞ and Cmax were 100.29% (94.31– 106.66%), 100.76% (94.60– 107.32%) and 93.14% (81.47– 106.48%). The comparison of PK parameters between MP-AzeFlu and Flu (commercially available) for the bioavailability evaluation showed that the LS mean ratios (90% CI) values for, AUC0–tlast, AUC 0–∞ and Cmax were 83.48% (69.81– 99.82%), 100.19% (87.34– 114.94%) and 81.91% (68.50– 97.95%).Conclusion: The study results confirm that neither the FLU or the AZE component in the combination product (MP-AzeFlu), nor the existing qualitative and quantitative differences in the formulation between the currently marketed AZE and FLU mono-product, display significant potential to impact the systemic exposure of AZE or FLU in Chinese subjects.Keywords: MP-AzeFlu, azelastine, fluticasone, allergic rhinitis, pharmacokinetics |
