Safety, Pharmacokinetics, and Pharmacodynamics of Midazolam Gel After Rectal Administration in Healthy Chinese Subjects
ConclusionMidazolam rectal gel may be a feasible alternative with a high level of acceptance in pediatric sedation and enhanced bioavailability compared to an oral formulation. The modeling results may help to disclose out the exposure-response relationship of midazolam rectal gel and support the design of an escalating-doses study and pediatric extrapolation study.Clinical trial registrationThe study was registered athttp://www.chinadrugtrials.org.cn (No. CTR20192350). (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - June 4, 2023 Category: Drugs & Pharmacology Source Type: research
Pharmacokinetics, Safety, and Tolerability of Single-Dose Orally Administered Venglustat in Healthy Chinese Volunteers
ConclusionVenglustat showed a favorable pharmacokinetic, safety, and tolerability profile in healthy Chinese volunteers following a single oral 15 mg dose.Clinical Trial Registry no.CTR20201012 (http://www.chinadrugtrials.org.cn) registered on 24 February 2021 and ChiCTR2200066559 (http://www.chictr.org.cn) retrospectively registered on 9 December 2022. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - June 3, 2023 Category: Drugs & Pharmacology Source Type: research
A Phase I Study to Evaluate the Pharmacokinetic Drug ‒Drug Interaction of HP501, Febuxostat, and Colchicine in Male Chinese Patients with Hyperuricemia
ConclusionsThe concomitant use of HP501, febuxostat, and colchicine did not produce clinically meaningful DDIs in terms of their pharmacokinetic properties.Clinical Trial RegistrationNo. CTR20212261 (http://www.chinadrugtrials.org.cn/) registered September 2021. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 30, 2023 Category: Drugs & Pharmacology Source Type: research
Factors Related to Placebo Response in Randomized, Double-Blind Clinical Trials of Antidepressants in Children and Adolescents: A Meta-regression Analysis
ConclusionSetting up a placebo lead-in period should be considered in future clinical trials of antidepressants in adolescents and children. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 24, 2023 Category: Drugs & Pharmacology Source Type: research
Newer Antiseizure Medications and Suicidality: Analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) Database
ConclusionWhen compared with older ASMs, four newer ASMs (lacosamide, clobazam, brivaracetam, and vigabatrin) were found to have significantly lower odds of suicidality, while perampanel was found to significantly increase the odds of suicidality. Pronounced variability (greater than 30 fold) in the proportion of FAERS reports associated with suicidality among the drugs studied was identified. The results of this case control study of FDA adverse event reports spanning 10 years and 6309 cases of suicidality expand our understanding of the safety profile of newer ASMs. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 15, 2023 Category: Drugs & Pharmacology Source Type: research
Improving Chronic Venous Disease Management with Micronised Purified Flavonoid Fraction: New Evidence from Clinical Trials to Real Life
AbstractChronic venous disease (CVD) develops in the microvessels, and is perpetuated by a vicious cycle of inflammation and endothelial activation, structural and functional changes to vessels and valves, and progressive venous hypertension. Data from animal models indicate that micronised purified flavonoid fraction (MPFF) has beneficial effects on a range of pathophysiological processes that contribute to CVD, including inflammation, micro-vessel permeability, valve and vessel wall remodelling, and reflux in microvalves. These effects explain its beneficial effects on the signs and symptoms of CVD, which have been seen ...
Source: Clinical Drug Investigation - May 12, 2023 Category: Drugs & Pharmacology Source Type: research
Evaluation of the Drug –Drug Interaction Potential of Ensitrelvir Fumaric Acid with Cytochrome P450 3A Substrates in Healthy Japanese Adults
ConclusionThe inhibitory effect for CYP3A was confirmed after the last dose of ensitrelvir, and the effect diminished over time. In addition, ensitrelvir at 375/125 mg showed CYP3A inhibitory potential similar to that at 750/250 mg. These findings can be used as a clinical recommendation for prescribing ensitrelvir with regard to concomitant medications.Clinical Trial RegistrationJapan Registry of Clinical Trials identifier: jRCT2031210202. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 12, 2023 Category: Drugs & Pharmacology Source Type: research
Foreword
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 12, 2023 Category: Drugs & Pharmacology Source Type: research
Efficacy of Eltrombopag with Immunosuppressive Therapy Versus Immunosuppressive Therapy Alone on Severe Aplastic Anaemia: A Systematic Review and Meta-analysis
ConclusionThis meta-analysis indicated that patients treated with additional eltrombopag for IST may have a higher rate of haematological response. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 11, 2023 Category: Drugs & Pharmacology Source Type: research
Quality of Life in Chronic Venous Disease: Bridging the Gap Between Patients and Physicians
AbstractChronic venous disease (CVD) has a negative impact on patients ’ quality of life (QoL). This was demonstrated in the recent Patient Journey on CVD study, which examined QoL in patients with early- and advanced-stage CVD (Clinical, Etiological, Anatomical and Pathophysiological classification C0 to C4), and the gaps between the way in which physicians and pati ents viewed the impact of CVD on QoL. The study was conducted in five countries (Brazil, China, Czech Republic, Italy and Russia) and included 100 patients with CVD and 60 CVD specialists. Patients completed the 14-item Chronic Venous Insufficiency Questionn...
Source: Clinical Drug Investigation - May 10, 2023 Category: Drugs & Pharmacology Source Type: research
Intra-Class Switch Among IL-23 Inhibitors for Plaque Psoriasis: Is It Worth It?
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 8, 2023 Category: Drugs & Pharmacology Source Type: research
Olipudase Alfa in Non-CNS Manifestations of Acid Sphingomyelinase Deficiency: A Profile of Its Use
AbstractOlipudase alfa (Xenpozyme ™) is an intravenously administered acid sphingomyelinase enzyme replacement therapy indicated to treat non-CNS manifestations of acid sphingomyelinase deficiency (ASMD) in adult and paediatric patients. It is the first and currently the only disease-modifying treatment for ASMD. Olipudase alfa tr eatment improves hepatosplenomegaly, lung function and platelet counts, along with multiple other pathological features of ASMD in adult and paediatric patients with ASMD. These benefits are sustained through at least 24 months of treatment. Olipudase alfa is generally well tolerated; infusion...
Source: Clinical Drug Investigation - May 3, 2023 Category: Drugs & Pharmacology Source Type: research
Safety of Janus Kinase inhibitors in Patients with Alopecia Areata: A Systematic Review
ConclusionsThe most common side effects of JAK inhibitors in patients with alopecia areata were headache and acne. The OR for upper respiratory tract infections varied from over 7-fold increased to comparable to placebo. The risk of serious adverse events was not increased. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - May 3, 2023 Category: Drugs & Pharmacology Source Type: research
Correction to: A Cost ‑effectiveness Analysis of iGlarLixi Versus IDegAsp and Appropriate Price Exploration of iGlarLixi for Type 2 Diabetes Mellitus Patients in China
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - April 28, 2023 Category: Drugs & Pharmacology Source Type: research
A Risk-Scoring Model for Severe Checkpoint Inhibitor-Related Pneumonitis: A Case –Control Study
ConclusionsThe simple risk-scoring model may predict severe CIP in lung cancer patients receiving ICIs. For patients with high scores, clinicians should use ICIs with caution or strengthen the monitoring of these patients. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - April 25, 2023 Category: Drugs & Pharmacology Source Type: research
