Results 301 to 310 of about 312,991 (333)

A Randomized Phase 1 Study Evaluating Pharmacokinetics, Safety, and Tolerability of a High‐Concentration, Long‐Acting Cabotegravir Formulation in Adults Without HIV

open access: yesClinical Pharmacology in Drug Development, EarlyView.
Abstract Long‐acting (LA) cabotegravir 200‐mg/mL (CAB200) injections are approved for HIV‐1 prevention and as a complete LA HIV‐1 treatment regimen with rilpivirine. A high‐concentration suspension formulation, cabotegravir 400 mg/mL (CAB400‐D), was developed to enable less frequent dosing and self‐administration. This phase 1, double‐blind, randomized
Kelong Han   +16 more
wiley   +1 more source

Effect of Cytochrome P450 3A Inhibition and Induction by Itraconazole and Rifampin on Tazemetostat Pharmacokinetics in Patients With Advanced Malignancies

open access: yesClinical Pharmacology in Drug Development, EarlyView.
Abstract This study (NCT04537715) investigated itraconazole (strong cytochrome P450 [CYP] 3A inhibitor) and rifampin (strong CYP3A inducer) on tazemetostat pharmacokinetics. In Part 1, patients received tazemetostat 400 mg orally on Days 1, 15, and 36, and 400 mg twice daily on Days 3‐14 and Days 21‐35.
Yingxue Chen   +6 more
wiley   +1 more source

A 2‐Part, Open‐Label, Phase 1 Bioequivalence and Food‐Effect Study of Ubrogepant in Healthy Adult Participants

open access: yesClinical Pharmacology in Drug Development, EarlyView.
Abstract This Phase 1 study of ubrogepant was conducted to establish the bioequivalence (BE) of the 50‐ and 100‐mg to‐be‐marketed (TBM) tablet formulations with the clinical trial (CT) 100‐mg tablet formulation and evaluate the food effect on the bioavailability of the 100‐mg TBM tablet. This 2‐part study enrolled healthy participants aged 18‐45 years.
Ramesh Boinpally, Joel M. Trugman
wiley   +1 more source

Microtracer‐Based Assessment of the Mass Balance, Pharmacokinetics, and Excretion of [14C]Berzosertib, an Intravenous ATR Inhibitor, in Patients With Advanced Solid Tumors: A Phase 1 Study

open access: yesClinical Pharmacology in Drug Development, EarlyView.
Abstract Berzosertib is a small‐molecule ataxia telangiectasia and Rad3‐related protein inhibitor. To assess the clearance mechanism(s) of berzosertib, a Phase 1, 2‐period, open‐label study was conducted in adults with advanced solid tumors who were treated with a single intravenous dose of 210 mg/m2 berzosertib containing approximately 3 µCi of [14C ...
Jayaprakasam Bolleddula   +12 more
wiley   +1 more source

The Role of Dl-Dihydroxy Phenyl Alanine (Dopa) on Plasma Transaminase Level Under Altitude Stress

open access: gold, 1973
A. K. Chatterjee   +4 more
openalex   +1 more source

Night‐Time Chronotherapy with Methylprednisolone Prevents an Acute Rejection in Pediatric Patients with Liver Transplantation: A Randomized Clinical Trial

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Concept of methylprednisolone chronotherapy to prevent acute rejections. While endogenous cortisol secretion rises in the early morning, the number of lymphocytes in the blood is higher at night, thus exhibiting an antiphase pattern to cortisol secretion. Therefore, compared with the daytime, the infiltration of lymphocytes into immune‐reactive tissues
Kentaro Ushijima   +11 more
wiley   +1 more source

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