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A multi-center, double-blind, randomized, three-arm, active and placebo-controlled, parallel group design to evaluate the bioequivalence using clinical endpoint of Tretinoin Gel Microsphere, 0.08 percent (Amneal Pharmaceuticals LLC, USA) with Retin-A Micro (tretinoin) Gel Microsphere 0.08 percent (Valeant Pharmaceuticals North America LLC) in subjects with acne vulgaris. - NIL

开始日期2024-07-26

申办/合作机构

Amneal Pharmaceuticals LLC

CTRI/2023/04/052062 / RecruitingN/A

A RANDOMIZED, DOUBLE-BLIND, MULTICENTRE, THREE ARM, ACTIVE AND PLACEBO-CONTROLLED, PARALLEL STUDY DESIGN TO EVALUATE THE BIOEQUIVALENCE USING CLINICAL ENDPOINT OF TRETINOIN GEL MICROSPHERE, 0.08% (AMNEAL PHARMACEUTICALS LLC, USA) WITH RETIN-A MICROÂ® (TRETINOIN) GEL MICROSPHERE 0.08% (VALEANT PHARMACEUTICALS NORTH AMERICA LLC, USA) IN SUBJECTS WITH ACNE VULGARIS

开始日期2023-04-30

申办/合作机构

Amneal Intermediate, Inc.

[+1]

NCT03562949 / Terminated临床3期

A Randomized, Multiple-Dose, Placebo-Controlled, Multi-Center Study Comparing Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg to QVAR® 40 mcg (Beclomethasone Dipropionate HFA), Inhalation Aerosol in Treatment of Subjects With Asthma

To compare the efficacy and safety profiles of Beclomethasone dipropionate Inhalation Aerosol, 40 mcg (test product) and QVAR 40 mcg (beclomethasone dipropionate HFA), Inhalation Aerosol (reference product) and to demonstrate that the efficacy of the 2 active products is superior to that of placebo in the treatment of subjects with asthma.

开始日期2018-12-06

申办/合作机构

Amneal Ireland Ltd.

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项与 Amneal Pharmaceuticals LLC 相关的文献（医药）

2024-02-01·Movement Disorders

Safety and Efficacy of IPX203 in Parkinson's Disease: The RISE‐PD Open‐Label Extension Study

Article

作者: Fisher, Stanley ; Banisadr, Ghazal ; Thakkar, Sandeep ; Visser, Hester ; Zeitlin, Leonid ; Dhall, Rohit ; Hauser, Robert A ; Espay, Alberto J ; Cloud, Leslie

AbstractBackgroundIPX203 is a novel oral extended‐release formulation of carbidopa/levodopa (CD/LD) developed to address the short half‐life of immediate‐release CD/LD. In the phase 3 RISE‐PD trial, IPX203 significantly improved “Good On” time in patients with Parkinson's disease compared with immediate‐release CD/LD.ObjectivesTo evaluate the safety and efficacy of IPX203 in an open‐label extension of the pivotal phase 3 study.MethodsThis 9‐month extension enrolled patients who completed the randomized, double‐blind trial. Key efficacy endpoints included Movement Disorder Society‐Unified Parkinson's Disease Rating Scale and Patient and Clinical Global Impression scores. Adverse events (AEs) were recorded.ResultsImprovements in efficacy were maintained and dosing frequency and total daily dose remained stable through the trial. A total of 52.7% of patients experienced ≥1 treatment‐emergent AE, mostly mild or moderate and occurred within the first 90 days of treatment.ConclusionsIn this phase 3 open‐label extension, IPX203 exhibited a favorable safety and tolerability profile and sustained efficacy of comparable magnitude to the end of the double‐blind study. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

2023-01-01·Clinical Parkinsonism & Related Disorders

Improving levodopa delivery: IPX203, a novel extended-release carbidopa-levodopa formulation

Article

作者: Banisadr, Ghazal ; LeWitt, Peter ; Burdick, Daniel ; Ellenbogen, Aaron ; Gunzler, Steven ; Dhall, Rohit ; Gil, Ramon ; D'Souza, Richard

IntroductionIPX203 is a novel oral extended-release (ER) formulation of carbidopa (CD) and levodopa (LD) developed to address the short half-life and limited area for absorption of LD in the gastrointestinal tract. This paper presents the formulation strategy of IPX203 and its relationship to the pharmacokinetics (PK) and pharmacodynamic profile of IPX203 in Parkinson's disease (PD) patients.MethodsIPX203 was developed with an innovative technology containing immediate-release (IR) granules and ER beads that provides rapid LD absorption to achieve desired plasma concentration and maintaining it within the therapeutic range for longer than can be achieved with current oral LD formulations. The PK and pharmacodynamics of IPX203 were compared with IR CD-LD in a Phase 2, open-label, rater-blinded, multicenter, crossover study in patients with advanced PD.ResultsPharmacokinetic data showed that on Day 15, LD concentrations were sustained above 50% of peak for 6.2 h with IPX203 vs. 3.9 h with IR CD-LD (P = 0.0002). Pharmacodynamic analysis demonstrated that mean MDS-UPDRS Part III scores prior to administration of the first daily dose were significantly lower among patients receiving IPX203 than IR CD-LD (LS mean difference -8.1 [25.0], P = 0.0255). In a study conducted in healthy volunteers, a high-fat, high-calorie meal delayed plasma LD T_max by 2 h, and increased C_max and AUC_tau by approximately 20% compared with a fasted state. Sprinkling capsule contents on applesauce did not affect PK parameters.ConclusionThese data confirm that the unique design of IPX203 addresses some of the limitations of oral LD delivery.

2021-07-04·Analytical Chemistry Letters

Implementing Analytical Quality by Design (AQbD) Approach for Simultaneous Estimation of Tadalafil and Macitentan by RP-HPLC Method

作者: Vyas, Amitkumar J. ; Lumbhani, Arvind ; Gol, Dhruvanshi A. ; Patel, Nilesh K. ; Chudasama, Alpesh ; Chavda, Jayant R. ; Patel, Ashok B. ; Patel, Ajay I.

The principle motive behind this work is to develop robust, low cost, and regulatory flexible method for Tadalafil and Macitentan by RP-HPLC using Anal. Quality by Design principles.Failure Mode and Effects Anal. was performed and the risk priority number was calculated, from this anal. independent variables were selected.Optimization of chromatog. condition was performed using Central Composite Design.The separation was achieved using phenomex gemini C18 (150 mm, 4.6 mm, 5μm) column using mobile phase as methanol: 10 mM ammonium formate (74.1 : 25.9% volume/volume) (pH: 6.8) at a flow rate 0.94 mL/ min with detection wavelength at 260 nm and 40°C column oven temperatureThis method was validated according to ICH Q2 (R1) guideline.Anal. Quality by Design method was numerically optimized with a desirability of 1.0.ANOVA result shows that model was significant for all responses.The method was found to be linear in the range of 0.1-25μg/mL for Macitentan and 0.4-100μg/mL for Tadalafil.Percentage recovery was found in the range of 98.6-101.7% for Macitentan and 98.8-101.8% for Tadalafil.The RSD of precision and repeatability was found beneath 1%.AQbD driven method can be highly suitable for anal. of Tadalafil and Macitentan without interference.

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