Comparative Bioavailability Study of a New Vitamin D3 Orodispersible Film Versus a Marketed Oral Solution in Healthy Volunteers
ConclusionThe new ODF 25000 I.U. formulation provided a valuable alternative to the marketed oral solution for therapeutic vitamin D supplementation, with a bioavailability that was slightly higher than that of the vitamin D3 oral solution administered under the same conditions.Trial RegistrationThe study was retrospectively registered with the ISRCTN Registry (Registry code: ISRCTN13208948) on 27 November 2020. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - January 16, 2022 Category: Drugs & Pharmacology Source Type: research
Stepping Forward to the Next Level: Totality of Evidence for the First High-Concentration Adalimumab Biosimilar, CT-P17
AbstractBiosimilar regulatory evaluation considers the totality of evidence gathered through analytical, non-clinical and clinical studies. CT-P17 is the first high-concentration (100 mg/mL), citrate-free adalimumab biosimilar to receive regulatory approval in Europe for all indications held by reference adalimumab, following comprehensive non-clinical and clinical development programmes. State-of-the art physicochemical and biological methods demonstrated quality, analytical and functional comparability between CT-P17 and reference adalimumab; non-clinical in vivo studies supported biosimilarity. Three phase I and two pha...
Source: Clinical Drug Investigation - January 13, 2022 Category: Drugs & Pharmacology Source Type: research
Therapeutic Drug Monitoring-Guided Adjuvant Tamoxifen Dosing in Patients with Early Breast Cancer: A Cost-Effectiveness Analysis from the Prospective TOTAM Trial
ConclusionsTDM-guided dose optimization of tamoxifen is estimated to save costs and increase QALYs for early breast cancer patients. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - January 12, 2022 Category: Drugs & Pharmacology Source Type: research
The Absolute Bioavailability, Absorption, Distribution, Metabolism, and Excretion of BI 425809 Administered as an Oral Dose or an Oral Dose with an Intravenous Microtracer Dose of [14C]-BI 425809 in Healthy Males
ConclusionsAfter normalization, the absolute bioavailability of tablet-form BI 425809 was 71.64%. The total recovery of [14C]-BI 425809 25 mg was high (96.7%), with low intraindividual variability and similar amounts excreted in urine and feces.Clinicaltrials.gov identifiersNCT03783000 and NCT03654170. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - December 22, 2021 Category: Drugs & Pharmacology Source Type: research
Opicapone for the Treatment of Parkinson ’s Disease & quot;Off & quot; Episodes: Pharmacology and Clinical Considerations
AbstractParkinson's disease (PD) is a common neurodegenerative disorder. It is also the fastest-growing neurodegenerative disorder and has more than doubled between 1990 and 2016. Parkinson ’s disease causes significant morbidity and disability from motor dysfunction, sleep disturbances, and cognitive and psychiatric symptoms. This paper reviews recent evidence in the treatment of PD “off” episodes with the novel drug opicapone, including its efficacy, safety, and clinical indica tions. Opicapone is a novel, peripherally acting catechol-O-methyl transferase (COMT) inhibitor used as adjunctive therapy to carbidopa/lev...
Source: Clinical Drug Investigation - December 21, 2021 Category: Drugs & Pharmacology Source Type: research
Semaglutide and Diabetic Retinopathy Risk in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials
ConclusionsSemaglutide was not associated with an increased risk of DR; however, caution regarding DR risk is needed for older patients or those with long diabetes duration when taking semaglutide. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - December 11, 2021 Category: Drugs & Pharmacology Source Type: research
Application of Multicriteria Decision Analysis to Determine the Value of Prophylaxis Relative to On-Demand Treatment in Hemophilia A and Emicizumab versus Replacement Therapy in the Greek Healthcare Setting
ConclusionsThis MCDA has shown that the prophylaxis strategy was perceived as a more valuable option for managing MtSHA patients when compared with the on-demand strategy. Moreover, emicizumab adds higher value and improves patient QoL compared with replacement therapy for MtSHA in Greece. Emicizumab addresses important unmet needs due to its improved efficacy and mode of administration. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - December 7, 2021 Category: Drugs & Pharmacology Source Type: research
Correction to: Filgotinib in Rheumatoid Arthritis: A Profile of Its Use
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - December 6, 2021 Category: Drugs & Pharmacology Source Type: research
Efficacy of Pitolisant 20 mg in Reducing Excessive Daytime Sleepiness and Fatigue in Patients with Obstructive Sleep Apnoea Syndrome: An Individual Patient Data Meta-analysis
ConclusionThe results provide evidence of a significant benefit of pitolisant in improving EDS and fatigue, irrespective of baseline conditions. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - December 2, 2021 Category: Drugs & Pharmacology Source Type: research
Safety and Efficacy of the FLECTOR (Diclofenac Epolamine) Topical System in Children with Minor Soft Tissue Injuries: A Phase IV Non-randomized Clinical Trial
ConclusionThe FLECTOR topical system safely and effectively provided pain relief for minor soft tissue injuries in the pediatric population, with minimal systemic nonsteroidal anti-inflammatory drug exposure and low potential risk of local or systemic adverse events.Clinical Trial RegistrationClinicalTrials.gov identifier NCT02132247. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 26, 2021 Category: Drugs & Pharmacology Source Type: research
Bioequivalence Study of Palbociclib Capsules in Healthy Chinese Subjects Under Fasting and Fed Conditions
ConclusionsPharmacokinetic bioequivalence of palbociclib in healthy subjects was established between the palbociclib test formulation and the reference formulation under fasting and fed conditions according to predetermined regulatory criteria. The two formulations were safe and well tolerated. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 26, 2021 Category: Drugs & Pharmacology Source Type: research
Comparative Efficacy of Ciltacabtagene Autoleucel in CARTITUDE-1 vs Physician ’s Choice of Therapy in the Long-Term Follow-Up of POLLUX, CASTOR, and EQUULEUS Clinical Trials for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
ConclusionsCilta-cel showed superior efficacy compared with physician ’s choice of treatment, making it a promising new treatment option for patients with triple-class exposed relapsed or refractory multiple myeloma. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 25, 2021 Category: Drugs & Pharmacology Source Type: research
Comparing Sacubitril/Valsartan Against Sodium-Glucose Cotransporter 2 Inhibitors in Heart Failure: A Systematic Review and Network Meta-analysis
ConclusionsIn patients with heart failure, sacubitril/valsartan was demonstrated to be superior to SGLT2 inhibitors in the treatment effect for the composite of heart failure hospitalisation and cardiovascular death, cardiovascular death, and long-term blood pressure. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 19, 2021 Category: Drugs & Pharmacology Source Type: research
An Open-Label Study of the Pharmacokinetics and Tolerability of Once-a-Day Fentanyl Citrate Patch in Japanese Pediatric and Adolescent Patients with Cancer Pain
ConclusionFentanyl citrate patch tended to result in a higher serum fentanyl concentration in pre-school patients than in school-aged, adolescent, and adult patients who received the same dose. The patch provided adequate pain control, was well tolerated, and did not cause respiratory adverse events.Trial Registration NumberJPRN-JapicCTI-183909. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 16, 2021 Category: Drugs & Pharmacology Source Type: research
Safety and Effectiveness of Letermovir in Allogenic Hematopoietic Stem Cell Transplantation Recipients: Interim Report of Post-marketing Surveillance in Japan
ConclusionsInterim data from this largest of real-world studies confirm the safety and effectiveness of letermovir for CMV prophylaxis in Japanese allo-HSCT recipients. Given the limited data on Asian patients for letermovir use, this survey will provide valuable information for medical decision-making in routine clinical practice, serving as a vital supplement to the results obtained from clinical trials. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - November 16, 2021 Category: Drugs & Pharmacology Source Type: research
