Clinical Pharmacology in Drug Development临床药理学与药物开发
Clinical Pharmacology in Drug Development(英文缩写 CLIN PHARM DRUG DEV),ISSN 2160-7648,eISSN 2160-7648,中文译名:临床药理学与药物开发 是一本学术期刊。本页汇总该期刊的最新影响因子、分区信息以及最新收录于 PubMed 的文献,帮助您快速了解期刊全貌。
发文量统计区间：2025-10-01 至 2026-09-30，按本站收录文献的发表日期统计。
期刊介绍
历年影响因子趋势
| JCR 数据年份 | 影响因子 | JCR 分区 |
|---|---|---|
| 2021 | 2.151 | Q4 |
| 2022 | 2.000 | Q4 |
| 2023 | 1.500 | Q3 |
| 2024 | 1.800 | Q3 |
| 2025 | 1.700 | Q3 |
Clinical Pharmacology in Drug Development 最新收录文献
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1. Pharmacokinetic and Bioequivalence Evaluation of Febuxostat 40 mg Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions.
PMID:日期:2026-10The objective of the current study was to evaluate the rate and extent of absorption, and confirm the bioequivalence of a test formulation and a reference formulation of febuxostat 40 mg tablets in healthy Chinese subjects under both fasting and fed conditions. An open-label, randomized, single-dose, single-center, two-sequence, two-period crossover Phase I study was implemented to assess the pharmacokinetic bioequivalence of the two formulations in 64 healthy volunteers (32 for fasting group, 32 for fed group). Subjects received a single oral dose of either the test or reference febuxostat 40 mg tablet under the corresponding condition, with a 7-day washout period between cycles. The geometric mean ratios and their 90% confidence intervals (CIs) of the peak plasma concentration ( ), area under the plasma concentration-time curve from time 0 to the last quantifiable time point ( ), and area under the plasma concentration-time curve from time 0 to infinity ( ) for the test versus reference formulation were calculated for bioequivalence evaluation. All 90% CIs fell within the pharmacokinetic bioequivalence acceptance range of 80%-125%. A total of 12 adverse events (AEs) were reported in 10 subjects in the fasting group and nine AEs in eight subjects in the fed group, all of which were mild in severity with no serious AEs observed. The test formulation of febuxostat 40 mg tablets was bioequivalent to the reference formulation in healthy Chinese subjects under both fasting and fed conditions, and both formulations were well tolerated.
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2. Pharmacokinetic and Pharmacodynamic Drug-Drug Interactions Between Cofrogliptin and Metformin in Healthy Subjects: A Single-Center, Single-Arm, Phase I Study in China.
PMID:日期:2026-09-30This single-center, single-arm, Phase I study evaluated drug-drug interactions (DDIs) between cofrogliptin and metformin in healthy Chinese subjects. Twenty-two subjects sequentially received metformin monotherapy (Days 1-4), cofrogliptin monotherapy (Days 6-34), and combination therapy (Days 38-47). Serial blood/urine samples were collected for pharmacokinetic (PK) and pharmacodynamic (PD) analyses. Cofrogliptin showed no significant impact on metformin's PK and PD properties: the geometric mean ratios (GMRs, metformin + cofrogliptin/metformin) with 90% confidence intervals (CIs) for metformin AUC, AUC C, Ae and Ratio, were 0.872 (0.809, 0.941), 0.900 (0.834, 0.971), 0.840 (0.743, 0.950), 0.899 (0.782, 1.032), and 0.994 (0.871, 1.136), respectively; 90% CIs for plasma glucose AUEC, AUEC, and EC of combination (combination vs cofrogliptin monotherapy) all fell within 0.80-1.25. Metformin did not statistically affect cofrogliptin's PK and PD properties, as the GMRs (metformin + cofrogliptin/cofrogliptin) (90% CIs) for cofrogliptin AUC over the dosing interval and C were 1.12 (1.072, 1.169) and 1.14 (1.057, 1.220), and AUEC, EC, and EC for dipeptidyl peptidase-4 inhibition rate were 1.01 (1.003, 1.015), 1.00 (1.001, 1.009), and 1.03 (1.005, 1.040), respectively. No deaths, serious adverse events, or severe hypoglycemia occurred. In conclusion, the combination of cofrogliptin and metformin had no clinically significant PK or PD DDIs in healthy Chinese subjects.
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3. A Phase I Study of Nimotuzumab Combined with Irinotecan in Chinese Patients with Advanced Solid Tumors.
PMID:日期:2026-09-30Nimotuzumab is an anti-epidermal growth factor receptor antibody. This Phase I study evaluated the pharmacokinetics and safety of nimotuzumab plus irinotecan in Chinese patients with advanced solid tumors. At single ascending dosage (SAD) stage, four cohorts (100, 200, 400, and 600 mg) of patients received nimotuzumab intravenously on Day 1, alongside irinotecan 180 mg/m on Day 8. Three weeks later, all patients in the four cohorts transferred to multiple ascending dosage (MAD) stage: nimotuzumab was administrated weekly for 6 weeks, alongside irinotecan (Days 1, 15, 29, 43, and 57, 180 mg/m). Primary objective was pharmacokinetics, safety and tolerability was also examined. From December 2012 to October 2014, in SAD and MAD stages, there were 28 and 39 patients with Stage IV solid tumors. The area under the concentration curve (AUC) for a single dose of nimotuzumab was 10.2 ± 2.7 (100 mg), 37.6 ± 10.0 (200 mg), 114.8 ± 35.5 (400 mg), 197.6 ± 32.0 (600 mg) (×100 h µg/mL), and for multiple dose, it was 26.7 ± 3.4 (100 mg), 87.1 ± 12.0 (200 mg), 193.4 ± 46.9 (400 mg) and 446.3 ± 100.7 (600 mg) (×100 h µg/mL). There was low incidence of rash and no dose-limiting toxicities occurred. This study indicated that nimotuzumab at doses ranging from 100 to 600 mg exhibited a manageable and tolerable safety profile.
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4. Pharmacokinetics, Immunogenicity, and Safety of a Modified YTE Antibody in Healthy Adults.
4. 一种改良YTE抗体在健康成人中的药代动力学、免疫原性和安全性PMID:日期:2026-09-30REGN17092, a fully human immunoglobulin (Ig) G1 antibody with M252Y/S254T/T256E (YTE) modification in the Fc portion, was assessed in a first-in-human study (ClinicalTrials.gov, NCT05923424). REGN17092 was designed to target the severe acute respiratory coronavirus 2 (SARS-CoV-2) S protein. However, due to the emergence of new SARS-CoV-2 variants, the program was discontinued. In this single-center, randomized, placebo-controlled, single-ascending-dose study, participants received a single IV dose of REGN17092 (300, 1200, or 2400 mg) or placebo, or a single SC dose of REGN17092 (300 or 1200) or placebo. Endpoints assessed included pharmacokinetics (PK), safety, and immunogenicity. Allometric scaling was used to predict the terminal half-life of REGN17092 and to ensure adequate exposure multiples relative to the exposure at the NOAEL. Forty participants were included. Mean concentrations of REGN17092 in serum increased in a dose-proportional manner and were consistent with linear PK for a single dose administered IV or SC. PK analysis of a single dose of REGN17092 administered IV or SC suggests that REGN17092 has a half-life of 80-90 days and showed detectable penetration into nasal fluid. No anti-drug antibody responses were noted. In this Phase 1 study, REGN17092 was tolerable with a long half-life, highlighting the value of YTE modification.
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5. Systemic Bioavailability of Topical Diclofenac: Sodium 1% Versus Diethylamine 1.16% and the Effect of Heat or Exercise in a Randomized Cross-Over Study.
PMID:日期:2026-09-30Diclofenac is a widely used topical nonsteroidal anti-inflammatory drug (NSAID) for pain and inflammation. This study evaluated the relative bioavailability of diclofenac from diclofenac sodium (DS) gel 1% versus diclofenac diethylamine (DEA) gel 1.16% and assessed whether adjunct heat or moderate exercise influences systemic absorption of diclofenac from DS gel 1%. General and local tolerability of DS gel 1% was also examined. Thirty-six adults aged ≥50 years were enrolled in a single-center, open-label, randomized, two-arm, three-way crossover study consisting of three 7-day treatment periods separated by 14-day washouts. Each sequence included DS gel 1%, DEA gel 1.16%, and DS gel 1% combined with either heat (one arm) or moderate exercise (other arm). Treatments were applied four times daily. Plasma diclofenac levels and 24-h urine samples were collected on Days 1 and 7 using a validated LC-MS/MS assay. Systemic exposure (AUC) of DEA gel versus DS gel was comparable (GMR 90.7%; 90% CI: 82.7-99.5). Heat resulted in an excursion of the lower bound of the AUC- 90% confidence interval below the standard lower bioequivalence bound of 80% (GMR 92.5%; 90% CI: 77.3-111.0), while exercise showed no meaningful effect (GMR 103%; 90% CI: 87.8-120.0). As expected, given similar plasma exposure between treatments, urinary excretion was also similar (∼0.5% of the administered dose), supporting comparable systemic disposition.
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7. A Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of HP501 in Male Chinese Gout Patients with Hyperuricemia.
7. 一项评估HP501在中国男性高尿酸血症痛风患者中安全性、药代动力学和药效学的剂量递增研究PMID:日期:2026-09HP501, a novel highly selective renal urate transporter 1 (URAT1) inhibitor, represents a promising therapeutic option for hyperuricemia. This Phase I study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of HP501 in Chinese gout patients. 37 patients with gout and hyperuricemia were enrolled in this single-center, open-label, dose-escalation study. Participants were sequentially assigned to receive HP501 at 60, 80, and 100 mg twice daily (BID) following single- and multiple-dose regimens. Safety assessments, PK parameters, and PD reductions were systematically evaluated. HP501 demonstrated an acceptable safety and tolerability profile across all dose cohorts. The most common adverse events (≥10% of patients) included gout flare (36.1%), prostatic hypertrophy (36.1%), elevated ALT (16.7%), and kidney stones (11.1%), all of which were mild to moderate in severity. PK analysis revealed dose-proportional increases in Cmax and AUC (60 to 100 mg BID), with corresponding dose-dependent reductions in serum UA levels. All patients achieved therapeutic UA targets (<360 µmol/L). These findings support the clinical advancement of HP501, with 60 to 100 mg BID identified as the recommended dose range for further investigation in subsequent trials. However, these findings are preliminary and limited by the single-center design, small sample size, and exclusion of female patients, warranting confirmation in larger, more diverse populations.
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8. A First-in-Japanese Phase 1, Double-Blind, Placebo-Controlled, Parallel-Cohort Study of Sefaxersen, an Antisense Oligonucleotide Targeting Complement Factor B, in Healthy Participants.
PMID:日期:2026-09Increased activity in the complement alternative pathway (AP) plays a key role in diseases such as IgA nephropathy (IgAN). This first-in-Japanese double-blind Phase 1 study investigated the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of sefaxersen (RO7434656), an antisense oligonucleotide targeting complement factor B messenger RNA. Healthy participants were randomized equally into four cohorts: placebo or sefaxersen 20, 40, or 70 mg. The PK, PD, and safety endpoints were monitored throughout the study and during the 90-day follow-up period. All 24 participants completed the study, with no new safety signals or clinically meaningful changes in blood chemistry, electrocardiogram, or vital signs observed. Plasma sefaxersen concentration demonstrated a biphasic PK profile, characterized by an initial rapid decline followed by a slow elimination. Sefaxersen decreased PD markers related to the complement AP selectively, without affecting the classical pathway, in a dose-dependent manner, and the PD effects persisted over 2 to 3 months. Sefaxersen was well tolerated by healthy Japanese participants, with a manageable safety profile. These findings support the inclusion of Japanese patients with IgAN in the global Phase 3 study (IMAGINATION, NCT05797610).
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9. Pharmacokinetic and Pharmacodynamic Bio-Similarity of ADL-018 to Innovator Omalizumab: A Randomized Study in Healthy Adults.
PMID:日期:2026-09Bioequivalence and safety of ADL-018, an omalizumab biosimilar, were compared with United States-licensed omalizumab (US-OMA) and European Union-approved omalizumab (EU-OMA), both approved for allergies. Healthy adults were randomized (1:1:1) to receive a dose of ADL-018, US-OMA, or EU-OMA (150 mg/mL). Pharmacokinetic (PK) parameters, including AUC, AUC, and C, were considered equivalent if 90% CIs of geometric mean ratios (GMRs) were within predefined equivalence margin (0.80-1.25) using ANCOVA model. Other PK parameters, pharmacodynamics (PD) (free/total immunoglobulin E [IgE]), immunogenicity, and safety were compared. Overall, 306 participants (n = 102 per arm) were dosed; 287 completed the study. Equivalence of primary PK parameters was confirmed for pairwise comparisons, with 90% CIs within the predefined margin (GMRs of ADL-018 vs US-OMA: AUC-1.08, AUC-1.07, C-1.05; GMRs of ADL-018 vs EU-OMA: AUC-1.06, AUC-1.06, C - 1.05; and GMRs of US-OMA vs EU-OMA: AUC-0.99, AUC-0.99, C-1.00). PK/PD parameters were comparable across arms. Increase in total IgE (AUEC ∼30,000 to 35,000 h IU/mL) and decrease in free IgE (AUEC ∼29,000 to 35,000 h IU/mL) were comparable across arms. Similar incidence of adverse events across arms (treatment-emergent adverse events: ADL-018, n = 6; US-OMA, n = 5; EU-OMA, n = 4) was observed. ADL-018 demonstrated PK/PD equivalence and comparable safety profile to reference omalizumab.
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10. Originality, Authorship, and Accountability in AI-Enabled Pharmaceutical Design.
PMID:日期:2026-09该文献暂无摘要。