Fangliang Gan

Pharmacokinetics and Bioequivalence of Tamsulosin Hydrochloride Extended‐Release Capsules in Healthy Chinese Volunteers: A Randomized, Open‐Label, Crossover Study Under Fasting and Fed Conditions

Lijie Du, Xiaolu Wang, Yi Zhang, Jiamin Yang et autres

Tamsulosin hydrochloride is a long-acting, highly selective α1A receptor antagonist, primarily used to treat benign prostatic hyperplasia. It effectively alleviates lower urinary tract symptoms, including dysuria, nocturia, and urgency caused by prostate enlargement. This study aimed to evaluate the pharmacokinetics and bioequivalence …

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Comparative Pharmacokinetics of Two Extended‐Release Tablet Formulations of Upadacitinib: Bioequivalence Assessment

Biao Sun, Li Zhao, Fangliang Gan, Qiong Zhan

Abstract The aim of this study is to evaluate the pharmacokinetic characteristics, bioequivalence, and safety of two brands of upadacitinib (UPA) extended‐release tablets (15 mg) in healthy Chinese subjects under fasting and postprandial conditions. The plasma concentration of UPA was determined by …

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Pharmacokinetics and Bioequivalence of Propafenone Hydrochloride Tablets under Fasting Conditions in Healthy Subjects

Yi Zhang, Meixia Hua, Lijie Du, Xuebo YIN et autres

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Pharmacokinetic and Bioequivalence Evaluation of Two Lercanidipine Hydrochloride Tablets in Healthy Chinese Volunteers

Biao Sun, Li Zhao, Fangliang Gan, Qiong Zhan

Abstract Lercanidipine hydrochloride is a third‐generation dihydropyridine calcium channel blocker used to treat mild‐to‐moderate hypertension. The aim of this study is to compare the pharmacokinetic characteristics of lercanidipine hydrochloride tablets (10 mg) in healthy Chinese volunteers after oral administration under fasting conditions …

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Pharmacokinetic and Bioequivalence Evaluation of Two Repaglinide Tablets Under Fasting and Fed Conditions in Healthy Chinese Volunteers

Biao Sun, Li Zhao, Fangliang Gan, Qiong Zhan

Abstract Repaglinide, an insulin secretagogue that predominantly lowers postprandial glucose, is approved for patients with type 2 diabetes inadequately controlled by diet, weight loss, and exercise. This study used a single‐center, randomized, open‐label, two‐formulation, single‐dose, four‐period, fully replicated, crossover design to evaluate …

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Pharmacokinetic Characterization and Bioequivalence of Sildenafil Citrate Orally Disintegrating Tablets in Healthy Volunteers

Yi Zhang, Lijie Du, Shirong Liu, Guiying Chen et autres

Abstract This study characterized the pharmacokinetic (PK) profile and evaluated the bioequivalence of sildenafil citrate under fasting conditions in Chinese subjects. A single‐center, randomized, open‐label, single‐dose, two‐sequence, two‐period crossover study was conducted. Thirty‐eight subjects were randomized (1:1) to the TR or RT …

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Pharmacokinetics, Bioequivalence, and Safety of Diclofenac Sodium Sustained‐Release Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions

Biao Sun, Li Zhao, Fangliang Gan, Qiong Zhan

Abstract The study aimed to evaluate the pharmacokinetics, bioequivalence, and safety of domestic diclofenac sodium sustained‐release tablets (0.1 g) and a reference formulation in healthy Chinese subjects. Two independent trials (fasting and fed conditions) were conducted with a single‐center, randomized, open‐label, single‐dose, …

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Pharmacokinetics and Bioequivalence of Ilaprazole Enteric‐Coated Tablets in Healthy Chinese Volunteers: A Two‐Sequence, Four‐Period, Fully Replicated Crossover Study

Linlin Du, Yi Zhang, Fangliang Gan, Jiamin Yang et autres

Abstract Ilaprazole enteric‐coated tablets are a novel proton pump inhibitor primarily used for the treatment of gastroesophageal reflux disease, with metabolism not affected by CYP2C19 genetic polymorphism. This study evaluated the pharmacokinetics and bioequivalence of two formulations of ilaprazole enteric‐coated tablets in …

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Pharmacokinetics and bioequivalence of two N‐acetylcysteine tablets in healthy Chinese volunteers under fasting and fed conditions

Xuebo YIN, Rui Xia, Huan Song, Yi Zhang et autres

N-acetylcysteine (NAC) is a derivative of cysteine with potent mucolytic and antioxidant properties. However, the pharmacokinetics of NAC tablets remain unclear in healthy Chinese subjects. This study aimed to assess the pharmacokinetics, bioequivalence, and safety of a domestically manufactured NAC tablet (600 …

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Pharmacokinetics, Bioequivalence, and Safety of Bromocriptine Mesylate Tablets in Healthy Chinese Subjects

Huan Song, Yujun Chen, Lianlian Chen, Xuebo YIN et autres

To investigate the pharmacokinetic characteristics of bromocriptine mesylate tablets in healthy Chinese subjects and to assess their bioequivalence and safety. A randomized, open-label, single-dose, four-period, two-sequence, complete crossover study was conducted. Forty healthy volunteers were enrolled and administered a single oral dose …

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Pharmacokinetics, Bioequivalence, and Safety of Levothyroxine Sodium Tablets in Healthy Chinese Subjects

Juan Jin, Chunrong Huang, Fangliang Gan, Tuo Li et autres

Recently, a local pharmaceutical company produced levothyroxine sodium tablets, an endogenous drug that helps improve water-salt metabolism and reduce myxedema. However, the bioequivalence of these tablets is not well known. The present study aimed to investigate the bioequivalence, pharmacokinetics, and safety of …

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A Randomized, Open‐Label, Two‐Sequence, Crossover Trial Evaluating the Bioequivalence, and Pharmacokinetics of Two Sulfamethoxazole/Trimethoprim Tablet Formulations in Healthy Chinese Volunteers Under Fasting Conditions

Peng Hui Xu, Yuan Liu, Hongcheng Li, Yuyan Lei et autres

Abstract The compound sulfamethoxazole (SMZ)/trimethoprim (TMP), a dual‐agent formulation comprising SMZ and TMP, exhibits synergistic bacteriostatic and bactericidal activity by disrupting folate metabolism pathways. This study assessed the bioequivalence (BE) of a generic compound SMZ/TMP tablet versus its innovator counterpart under fasting …

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