An Evaluation of the Pharmacokinetics, Safety, and Tolerability of Aclidinium/Formoterol Fixed-Dose Combination Administered in Chinese Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease
ConclusionsAclidinium/formoterol 400/12 µg twice daily was well-tolerated in patients from China with moderate-to-severe COPD. Safety findings were consistent with the known safety profile.Clinical Trial IdentifierClinicalTrials.gov, NCT03276078. (Source: Drugs in R&D)
Source: Drugs in R&D - February 8, 2022 Category: Drugs & Pharmacology Source Type: research
NLRP3 Inhibitor Tranilast Attenuates Gestational Diabetes Mellitus in a Genetic Mouse Model
ConclusionsOur data clarified the protective role of the NLRP3 inhibitor, tranilast, on GDM by inhibiting the activation of the NLRP3 inflammasome as well as inflammatory responses. The findings mean tranilast might serve as a therapeutic drug to treat GDM. (Source: Drugs in R&D)
Source: Drugs in R&D - February 5, 2022 Category: Drugs & Pharmacology Source Type: research
In Vitro Stability and Recovery Studies of Pimavanserin in Water and in Different Vehicles Orally Administered
ConclusionThese results support the ability of pimavanserin to be given orally by emptying the capsule contents into soft foods or liquids in accordance with the product label. (Source: Drugs in R&D)
Source: Drugs in R&D - February 2, 2022 Category: Drugs & Pharmacology Source Type: research
Pharmacokinetics of Diazepam and Its Metabolites in Urine of Chinese Participants
ConclusionThe results regarding diazepam pharmacokinetics in urine would be of great help in forensic science and drug screening. (Source: Drugs in R&D)
Source: Drugs in R&D - January 31, 2022 Category: Drugs & Pharmacology Source Type: research
Effect of Severe Renal Impairment on the Safety, Tolerability, and Pharmacokinetics of AMG 986
ConclusionsThe results of this study support the enrollment of HF patients with RI to clinical trials of AMG 986 without the need for dose adjustments.Trial Registration NumberNCT03318809 (registered: October 24, 2017). (Source: Drugs in R&D)
Source: Drugs in R&D - January 29, 2022 Category: Drugs & Pharmacology Source Type: research
Bioequivalence and Safety Assessment of Two Formulations of Metformin Hydrochloride Sustained-Release Tablets (Yuantang ® SR and Glucophage® XR) Under Fed Conditions in Healthy Chinese Adult Subjects: An Open-Label, Two-Way Crossover, Sequence Randomized Phase I Clinical Trial
ConclusionsYuantang® SR was confirmed to be a well tolerated and bioequivalent alternative to Glucophage® XR when taken under postprandial conditions in healthy Chinese volunteers. The Clinical Trials Registry Platform used for this study washttp://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml. The trial registration numbers (TRNs) and dates of registrations were CTR20180476 (19 April 2018) for this clinical trial and CTR20171595 (11 January 2018) for the pilot trial. (Source: Drugs in R&D)
Source: Drugs in R&D - January 21, 2022 Category: Drugs & Pharmacology Source Type: research
A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of Subcutaneous Eflapegrastim in Healthy Japanese and Caucasian Subjects
ConclusionsEflapegrastim was safe and well tolerated at doses up to 270 μg/kg in healthy Japanese and Caucasian subjects. In both ethnic groups, eflapegrastim showed dose-dependent PK and the exposure to eflapegrastim was positively correlated with ANC and CD34+ cell count. The comparable PK and PD profiles of eflapegrastim in Japanese and Caucasian subjects may indicate the same dosage regimen is acceptable.Clinical Trial RegistrationClinicalTrials.gov: NCT01037543 (23 December 2009). (Source: Drugs in R&D)
Source: Drugs in R&D - January 6, 2022 Category: Drugs & Pharmacology Source Type: research
Pharmacokinetics and Pharmacodynamics of Ibrexafungerp
AbstractOn 2 June, 2021, the US Food and Drug Administration approved ibrexafungerp (formerly MK-3118 and SCY-078) for the treatment of vulvovaginal candidiasis, also known as vaginal yeast infection. Ibrexafungerp is the first drug approved in a novel antifungal class in more than two decades, and the Food and Drug Administration ’s decision was based on positive results from two pivotal phase III studies in which oral ibrexafungerp proved both safe and effective in patients with vulvovaginal candidiasis. The decision was also based on substantial preclinical and clinical work in both the pharmacokinetics and pharmacod...
Source: Drugs in R&D - December 27, 2021 Category: Drugs & Pharmacology Source Type: research
The Pitfalls of Abnormal Laboratory Value Interpretation in Vaccine Clinical Trials: The Example of Asymptomatic Transient Neutropenia
AbstractHematological and clinical chemistry measurements are an integral part of vaccine safety monitoring. While adopting a conservative approach is important to exclude potential risks for patients, the rationale and methodology underlying the assessment of given adverse events have to be well grounded to avoid raising unfounded concerns. Using asymptomatic transient neutropenia as an example, this paper aims to address the complexity of interpreting abnormal hematological values in vaccine clinical trials and to evaluate the validity of using neutrophil count cut-off points to assess neutropenia in the context of safet...
Source: Drugs in R&D - December 18, 2021 Category: Drugs & Pharmacology Source Type: research
Pharmacokinetics and Bioequivalence of Sitagliptin Phosphate/Metformin Hydrochloride Tablets in Healthy Chinese Subjects: A Randomized, Open-Label, Crossover Study
ConclusionThe two formulations of sitagliptin phosphate/metformin hydrochloride tablets were bioequivalent under fasting and fed conditions in healthy Chinese subjects. (Source: Drugs in R&D)
Source: Drugs in R&D - November 30, 2021 Category: Drugs & Pharmacology Source Type: research
Coenzyme Q10 in the Treatment of Heart Failure with Preserved Ejection Fraction: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
ConclusionsIn this pilot trial in elderly patients with HFpEF, treatment with CoQ10 did not significantly affect echocardiographic indices of diastolic function and serum NT-proBNP levels.Trial RegistrationThis trial was registered in the US National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT02779634). (Source: Drugs in R&D)
Source: Drugs in R&D - November 26, 2021 Category: Drugs & Pharmacology Source Type: research
The Anti-inflammatory Effect of Dexmedetomidine Administration on Patients Undergoing Intestinal Surgery: A Randomized Study
ConclusionDexmedetomidine administration in patients undergoing intestinal surgery inhibited the surgery-induced inflammatory reactions. (Source: Drugs in R&D)
Source: Drugs in R&D - November 9, 2021 Category: Drugs & Pharmacology Source Type: research
Acknowledgement to Referees
(Source: Drugs in R&D)
Source: Drugs in R&D - November 9, 2021 Category: Drugs & Pharmacology Source Type: research
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
ConclusionsVIR-2218 showed favorable pharmacokinetics in healthy volunteers supportive of subcutaneous dosing and continued development in patients with chronic HBV infection.Clinical Trial Registration NoNCT03672188, September 14, 2018. (Source: Drugs in R&D)
Source: Drugs in R&D - November 6, 2021 Category: Drugs & Pharmacology Source Type: research
Pharmacokinetics of the Melanocortin Type 1 Receptor Agonist PL8177 After Subcutaneous Administration
ConclusionPL8177 administration resulted in a consistent pharmacokinetic profile. The measured exposure levels resulted in pharmacologically active PL8177 concentrations at the targeted MC1R. Rapid absorption was seen in healthy volunteers, and multiple-dose administration over 7 days resulted in pharmacokinetic characteristics similar to those observed after single-dose administration. Results support the continued development of PL8177 to treat immunologic and inflammatory conditions. (Source: Drugs in R&D)
Source: Drugs in R&D - October 25, 2021 Category: Drugs & Pharmacology Source Type: research
