Clinical Pharmacology in Drug Development 
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This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.Population Pharmacokinetic Model of N ‐Acetylcysteine During Periods of Recurrent Hypoglycemia in Healthy Volunteers
AbstractRecurrent hypoglycemia leads to impaired awareness of hypoglycemia where the blood glucose threshold that elicits the counterregulatory response is lowered. Hypoglycemia-induced oxidative stress is hypothesized to contribute to impaired awareness of hypoglycemia development and hypoglycemia-associated autonomic failure. Our group conducted a randomized, double-blinded, placebo-controlled, crossover study in healthy individuals undergoing experimentally induced recurrent hypoglycemia to evaluate the impact of intravenous N-acetylcysteine (NAC) during experimental hypoglycemia to preserve the counterregulatory respon...
Source: Clinical Pharmacology in Drug Development - November 8, 2023 Category: Drugs & Pharmacology Authors: Mohamed S. Fayed,
Jillian Brooks,
Elizabeth R. Seaquist,
Anjali Kumar,
Amir Moheet,
Lynn Eberly,
Usha Mishra,
Lisa D. Coles Tags: Original Article Source Type: research
Pharmacokinetics and Safety Evaluation of Single ‐Dose Saroglitazar Magnesium in Subjects with Hepatic Impairment
AbstractSaroglitazar magnesium, a dual peroxisome proliferator –activated receptor agonist, is under evaluation for treating various liver conditions. While the pharmacokinetics (PK) of saroglitazar have been extensively studied in diverse preclinical models and healthy subjects, a comprehensive assessment of its PK behavior under conditions of hepatic impair ment is lacking. In this Phase 1, open-label, parallel-group study, the PK of a single dose of 4-mg saroglitazar magnesium was investigated in subjects having varying degrees of hepatic impairment with and without portal hypertension compared with appropriately matc...
Source: Clinical Pharmacology in Drug Development - November 2, 2023 Category: Drugs & Pharmacology Authors: Eric Lawitz,
Deven Parmar,
Taufik Momin,
Farheen Shaikh,
Harilal Patel,
Helen Hayes,
Kimberly Swint Tags: Original Article Source Type: research
Issue Information
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - November 1, 2023 Category: Drugs & Pharmacology Tags: Issue Information Source Type: research
The Pharmacokinetics, Safety, and Tolerability of Rimegepant 75 mg Are Similar in Elderly and Nonelderly Adults: A Phase 1, Open‐Label, Parallel‐Group, Single‐Dose Study
AbstractRimegepant is a small-molecule calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine ± aura and preventive treatment of migraine in adults. The pharmacokinetics of rimegepant in elderly and nonelderly subjects were evaluated. In an open-label Phase 1 study, 14 elderly (aged 65 years or older) and 14 nonelderly (aged 18 to less than 45 years) subjects each received a single oral dose of rimegepant 75 mg. Blood samples were collected before dosing and through 96 hours after dosing. The pharmacokinetic parameters of rimegepant after a single dose were similar in both ag...
Source: Clinical Pharmacology in Drug Development - October 31, 2023 Category: Drugs & Pharmacology Authors: Rajinder Bhardwaj,
Beth Morris,
Richard Bertz,
Robert Croop,
Jing Liu Tags: Original Article Source Type: research
Pharmacokinetics and Drug –Drug Interaction of Allisartan Isoproxil and Indapamide Sustained‐Release Formulation
AbstractAllisartan isoproxil (AI) is an angiotensin II type 1 receptor blocker and be converted into the active substance EXP3174 in vivo. We evaluated the drug –drug interactions of AI and an indapamide sustained-release (Ind SR) preparation, as well as the pharmacokinetic characteristics and safety of AI and Ind SR in healthy subjects. The trial was set up in 6 sequences and 3 cycles, and each cycle contained a 7-day washout period. Subjects received 3 different trial drugs (A, AI; B, Ind SR; C, AI + Ind SR) during 3 different cycles. Twenty-four subjects were enrolled in the clinical trial. Of these, 22 completed th...
Source: Clinical Pharmacology in Drug Development - October 18, 2023 Category: Drugs & Pharmacology Authors: Wu Yi,
Sisi Lin,
Rui Hao,
Yiming Shao,
Yannan Wang,
Jin Yu,
Lu Fang,
Jingjing Zhu,
Aiwei Wang,
Yanfang Wu,
Hua Huang,
Chongyang Deng,
Jingchao Sun,
Hongcan Zhao,
Ying Wang,
Xiangming Tong Tags: Original Article Source Type: research
Effect of Paricalcitol Combined with Cinacalcet on Calcium and Phosphorus Metabolism in Patients Receiving Maintenance Hemodialysis
This study was designed to compare the beneficial effects of paricalcitol combined with or without cinacalcet on calcium and phosphorus metabolism in patients undergoing maintenance hemodialysis (MHD). A total of 140 patients who received MHD in our hospital from March 2021 to March 2022 were randomly divided into a control group (intravenous paricalcitol, n = 70) and a test group (intravenous paricalcitol combined with oral cinacalcet, n = 70). Clinical baseline data and relevant laboratory parameters before treatment were compared. Additionally, calcium, phosphorus, intact parathyroid hormone in serum were measured and c...
Source: Clinical Pharmacology in Drug Development - October 10, 2023 Category: Drugs & Pharmacology Authors: Feng ‐yun Zheng,
Ya‐yin Tan,
Jia‐jun Zhou Tags: Original Article Source Type: research
Pharmacokinetics, Tolerability, and Safety of Glecaprevir/Pibrentasvir Co ‐formulated Bilayer Tablet Following Repeated Administration in Healthy Chinese Adults
AbstractGlecaprevir (GLE)/pibrentasvir (PIB) is an all-oral, interferon- and ribavirin-free, pan-genotypic fixed-dose combination regimen approved for the treatment of all major genotypes of hepatitis C virus (HCV) infection in many countries worldwide. To support clinical development in China, an open-label, single-center phase 1 study was conducted to evaluate the pharmacokinetics, safety, and tolerability of GLE/PIB in healthy Chinese adults in Mainland China. Eighteen participants received 3 tablets of coformulated GLE/PIB 100/40 mg once daily (QD) for 7 days. Following GLE/PIB 300 mg/120 mg administration, GLE and...
Source: Clinical Pharmacology in Drug Development - October 3, 2023 Category: Drugs & Pharmacology Authors: Hari V. Kalluri,
Rajneet K. Oberoi,
Qian Chen,
Qi Jiang,
Armen Asatryan,
Negar N. Alami,
Chen Yu,
Wei Liu Tags: Original Article Source Type: research
Issue Information
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - October 3, 2023 Category: Drugs & Pharmacology Tags: Issue Information Source Type: research
Correction to Rimegepant 75 mg in Subjects With Hepatic Impairment: Results of a Phase 1,Open‐Label, Single‐Dose, Parallel‐Group Study
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - October 3, 2023 Category: Drugs & Pharmacology Tags: Correction Source Type: research
