A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study of Nebulized Revefenacin Inhalation Solution in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD).

This study is a phase III clinical study to assess the efficacy and safety of Revefenacin inhalation solution 175 mcg administered once daily via nebulization for 12 weeks compared to placebo in a population of Chinese subjects with moderate to very severe COPD.

Start Date10 Nov 2021

Sponsor / Collaborator

Mylan Pharma UK Ltd.

NCT05207111 / CompletedPhase 1

Single-Dose Fasting Bioavailability Study of Mylan's Revefenacin Inhalation Solution, 175 mcg/3 mL in Healthy Chinese Adult Male and Female Volunteers

Single-Dose Fasting Bioavailability Study of Revefenacin Inhalation Solution, 175 mcg/3 mL in 24 Healthy Chinese Adult Male and Female Volunteers. This study will evaluate the safety and tolerability of Revefenacin Inhalation Solution in the Chinese population. For the determination of the pharmacokinetic disposition of the formulations, The bioavailability of Revefenacin Inhalation Solution, 175 mcg/3 mL will be assessed through various pharmacokinetic parameters derived from the plasma concentration-time curves of revefenacin and its active metabolite, THRX-195518.

Start Date23 Sep 2021

Sponsor / Collaborator

Mylan Pharma UK Ltd.

NCT02474017 / CompletedPhase 1

An Open Study to Assess the Robustness of the CRC749 Device by Pharmaceutical Performance Following Twice Daily Dosing of MGR001 Administered Via Oral Inhalation in Subjects With Asthma or Chronic Obstructive Pulmonary Disease (COPD)

To confirm the robustness of the CRC749 inhaler.

Start Date01 May 2015

Sponsor / Collaborator

Mylan Pharma UK Ltd.

100 Clinical Results associated with Mylan Pharma UK Ltd.

0 Patents (Medical) associated with Mylan Pharma UK Ltd.

Literatures (Medical) associated with Mylan Pharma UK Ltd.

01 Dec 2020·Journal of Aerosol Medicine and Pulmonary Drug DeliveryQ4 · MEDICINE

Wixela Inhub: Dosing Performance In Vitro and Inhaled Flow Rates in Healthy Subjects and Patients Compared with Advair Diskus

Q4 · MEDICINE

Article

Author: Parker, James ; Cooper, Andrew ; Wallace, Róisín ; Berry, Mark ; Ward, Jon ; Allan, Richard

Background: Wixela™ Inhub™ is a fluticasone propionate/salmeterol dry powder inhaler developed as a generic equivalent of Advair Diskus^® for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Wixela Inhub and Advair Diskus are comparable in terms of functionality, user interface, and device resistance. The primary objectives of the studies were to evaluate in vitro dose delivery with Wixela Inhub compared with Advair Diskus at relevant flow rates and to explore inhalation profiles generated by patients with asthma or COPD. Methods:In vitro studies: Emitted dose (ED) and individual dose aerodynamic particle size distribution (APSD) were measured at flow rates ranging from 30 to 90 L min^-1. Patient inhalation study: Inhalation profile recording was conducted three times in each patient (40 children with asthma, 14 adults with asthma, and 14 adults with severe-to-very-severe COPD) with an empty Inhub in an open-label study. The primary endpoint was peak inhaled flow rate (PIFR). An additional endpoint was peak pressure drop. Results:In vitro studies: ED and APSD delivered from Wixela Inhub showed low flow dependency across the patient-relevant flow-rate range. Wixela Inhub gave in vitro performance comparable with Advair Diskus for all strengths and flow rates. Patient inhalation study: For Inhub, mean PIFR was lowest for children with asthma ages 4 to 7 years (50.6 L min^-1) and highest for adults with asthma (74.8 L min^-1). For adults with severe-to-very-severe COPD, mean PIFR was 69.5 L min^-1 with Inhub. The PIFRs observed with Diskus were higher than those with Inhub, consistent with slightly higher resistance measured in vitro. The difference in resistance did not impact demonstration of bioequivalence and does not impact substitutability of the product. Peak pressure drop values were comparable between Diskus and Inhub. Conclusions: Comparable in vitro performance of Wixela Inhub to Advair Diskus confirmed that Wixela Inhub is a generic equivalent to Advair Diskus across all patient groups.

01 Apr 2020·Journal of Aerosol Medicine and Pulmonary Drug Delivery

Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma

Article

Author: Ng, Dik ; Kerwin, Edward M. ; White, Martha V. ; Miller, S. David ; Haughie, Scott ; Allan, Richard ; Ward, Jonathan K.

Background: Wixela^® Inhub^® is a dry powder inhaler approved as a generic equivalent to Advair^® Diskus^® (fluticasone propionate [FP]/salmeterol fixed-dose combination) for patients with asthma or chronic obstructive pulmonary disease (COPD). This study aimed at confirming the local (lung) therapeutic equivalence of both the FP and salmeterol components of Wixela Inhub (test [T]) to Advair Diskus (reference [R]) after inhalation. Methods: This randomized, double-blind, double-dummy, placebo-controlled, parallel-group study in patients ≥18 years with mild-to-moderate persistent asthma compared the local therapeutic equivalence (using forced expiratory volume in 1 second [FEV₁]) of FP/salmeterol (100/50 μg) after inhaled delivery via T and R. Results: Randomized patients (N = 1127) received T (n = 512), R (n = 512), or placebo (n = 103). T and R significantly increased day 1 FEV₁ area under the effect curve over 12 hours of the change from baseline (AUC_[0-12]) and day 29 trough FEV₁ over placebo, indicating that these endpoints were sufficiently sensitive for evaluation of bioequivalence. On day 1, T and R each increased FEV₁ AUC_(0-12) over placebo (3.134 L•h [T], 2.677 L•h [R]; each p < 0.0001). Following twice-daily dosing for 28 days, T and R also each increased trough FEV₁ (measured on day 29) over placebo (235 mL [T], 215 mL [R]; each p < 0.0001). Least-squares mean T/R ratios (90% confidence intervals) for day 1 FEV₁ AUC_(0-12) and day 29 trough FEV₁ were 1.120 (1.016-1.237) and 1.069 (0.938-1.220), respectively, indicating that T and R were bioequivalent for both co-primary endpoints. FP/salmeterol was well tolerated when administered via either T or R. Conclusions: These results demonstrate that the therapeutic effects of Wixela Inhub are bioequivalent to Advair Diskus in the lung. Wixela Inhub represents a therapeutically equivalent new FP/salmeterol treatment option for use in the treatment of asthma and COPD.

01 Feb 2020·Journal of Aerosol Medicine and Pulmonary Drug Delivery

Equivalent Systemic Exposure to Fluticasone Propionate/Salmeterol Following Single Inhaled Doses from Advair Diskus and Wixela Inhub: Results of Three Pharmacokinetic Bioequivalence Studies

Article

Author: Wood, Nolan ; Allan, Richard ; Ward, Jon ; Haughie, Scott

Background: Wixela^® Inhub^® was developed to deliver inhaled fluticasone propionate/salmeterol (FP/S) combination as a substitutable generic equivalent to Advair^® Diskus^®. These studies aimed to confirm the pharmacokinetic bioequivalence (BE) of FP/S after single doses of Wixela Inhub (test [T]) and Advair Diskus (reference [R]). Methods: Three open-label, randomized, two-way crossover, single-dose studies in healthy subjects (N = 66 each) compared the systemic exposure of FP and salmeterol after inhalation from three dose strengths of FP/S (100/50, 250/50, or 500/50 μg) delivered from T and R. Primary BE endpoints were the area under the plasma concentration-time curve from time = 0 to the last measurable concentration (AUC_(0-t)) and the maximum observed plasma concentration (C_max) for both FP and S. The BE acceptance criteria specified that the 90% confidence intervals (CIs) of the geometric mean T/R ratios for AUC_(0-t) and C_max can be contained within 0.80-1.25 for both FP and salmeterol. Results: Wixela Inhub met the acceptance criteria for BE for FP and salmeterol at each dose strength. Estimated AUC_(0-t) and C_max geometric mean ratios (T/R [90% CI]) for FP were, respectively, 1.04 (1.00-1.08) and 0.92 (0.87-0.96) for 100/50 μg FP/S, 1.07 (1.02-1.13) and 1.01 (0.95-1.07) for 250/50 μg, and 0.97 (0.92, 1.00) and 0.90 (0.86-0.93) for 500/50 μg. Estimated AUC_(0-t) and C_max ratios for salmeterol were, respectively, 1.08 (1.04-1.11) and 1.00 (0.94-1.04) for 100/50 μg FP/S, 1.03 (0.99-1.07) and 0.93 (0.87-1.00) for 250/50 μg, and 1.00 (0.96-1.04) and 0.86 (0.81-0.91) for 500/50 μg. FP/S at all doses via both T and R was comparably well tolerated. Conclusions: Wixela Inhub was bioequivalent to Advair Diskus at all three dose strengths for both FP and S, providing direct evidence of equivalent systemic safety and indirect evidence for equivalent pulmonary deposition.

100 Deals associated with Mylan Pharma UK Ltd.

100 Translational Medicine associated with Mylan Pharma UK Ltd.

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Drug(Targets)	Indications	Global Highest Phase

Revefenacin ( mAChRs )	-	Pending
Fluticasone propionate/Salmeterol xinafoate ( GR x cPLA2α x β2-adrenergic receptor )	Pulmonary Disease, Chronic Obstructive More	Pending

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