Bioequivalence Between Generic and Branded Lamotrigine in People With Epilepsy: The EQUIGEN Randomized Clinical Trial
Sign Up to like & getrecommendations! Published in 2017 at "JAMA Neurology"
DOI: 10.1001/jamaneurol.2017.0497
Abstract: Importance Switching between generic antiepileptic drugs is a highly debated issue that affects both clinical care and overall health care costs. Objective To evaluate the single-dose pharmacokinetic bioequivalence of 3 (1 branded and 2 generic… read more here.
Keywords: bioequivalence; trial; study; drug ... See more keywords
Chiral bioanalytical methods in bioequivalence studies of intravenous vs. oral formulations of ibuprofen.
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DOI: 10.1002/chir.23258
Abstract: According to the Ibuprofen Product-Specific Bioequivalence Guidance of the European Medicines Agency, achiral bioanalytical methods are considered acceptable for demonstration of bioequivalence of ibuprofen-containing products. The aim of this investigation is to compare the bioequivalence… read more here.
Keywords: bioequivalence; sum enantiomers; ibuprofen; bioanalytical methods ... See more keywords
Pharmacokinetics, Bioequivalence, and Safety Studies of Amlodipine Besylate in Healthy Subjects
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DOI: 10.1002/cpdd.1064
Abstract: This study aimed to evaluate the bioequivalence of 2 amlodipine besylate tablet formulations, a generic formulation and an original formulation, and to investigate their pharmacokinetic and safety profiles. This study was designed as a randomized,… read more here.
Keywords: safety; besylate; concentration; bioequivalence ... See more keywords
Pharmacokinetics and Bioequivalence Evaluation of 2 Olmesartan Medoxomil and Amlodipine Besylate Fixed‐Dose Combination Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions
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DOI: 10.1002/cpdd.1086
Abstract: Combined antihypertensive drugs have become the basic method of treating hypertension. Olmesartan and amlodipine, as representative drugs of angiotensin receptor blockers and calcium channel blockers, were developed as a compound formulation for antihypertensive treatment. The… read more here.
Keywords: time; fasting fed; fed conditions; bioequivalence ... See more keywords
A Single‐blind, Randomized, Single‐dose, Two‐sequence, Two‐period, Crossover Study to Assess the Bioequivalence between Two Oral Tablet Formulations of Rivaroxaban 20 mg in Healthy Mexican Volunteers
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1092
Abstract: The objective of this study was to demonstrate the bioequivalence of 2 oral tablet formulations of rivaroxaban 20 mg in healthy Mexican volunteers under fed conditions. This phase I, single‐blind, single‐dose, randomized, two‐sequence, two‐period crossover… read more here.
Keywords: single dose; period; mexican volunteers; bioequivalence ... See more keywords
Pharmacokinetics and Bioequivalence of 2 Azithromycin Tablet Formulations: A Randomized, Open‐Label, 2‐Stage Crossover Study in Healthy Volunteers
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DOI: 10.1002/cpdd.1098
Abstract: The current study aimed to assess the bioequivalence of a new branded azithromycin with the reference formulation. An open‐label, randomized, 2‐stage, crossover study design was implemented involving 77 healthy volunteers under fasting conditions. Each volunteer… read more here.
Keywords: reference; crossover study; bioequivalence; open label ... See more keywords
Pharmacokinetics and Bioequivalence of Single‐Oral‐Dose Linagliptin: A Randomized, 2‐Period Crossover Trial in Chinese Healthy Subjects Under Fasting and Fed Conditions
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1104
Abstract: The bioequivalence of the reference and test linagliptin formulations was assessed in healthy Chinese subjects under fasting and fed conditions. The study was designed as a single‐dose, randomized, open‐label, 2‐period crossover study with a 35‐day… read more here.
Keywords: fasting fed; period; reference; test ... See more keywords
Pharmacokinetics and Bioequivalence of Two Formulations of Rosuvastatin Following Single‐dose Administration in Healthy Chinese Subjects Under Fasted and Fed Conditions
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DOI: 10.1002/cpdd.1112
Abstract: The main objective of the study was to evaluate the bioequivalence of two rosuvastatin calcium tablets in healthy Chinese subjects under fasted and fed conditions. The study was carried out using a randomized, open‐label, two‐formulation,… read more here.
Keywords: single dose; fasted fed; fed conditions; bioequivalence ... See more keywords
A Single‐dose, Two‐Period Crossover Bioequivalence Study Comparing Two Liraglutide Formulations in Healthy Chinese Subjects
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DOI: 10.1002/cpdd.1187
Abstract: Liraglutide, a glucagon‐like peptide 1 receptor agonist, is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. The original liraglutide products are costly, which limits patient… read more here.
Keywords: single dose; chinese subjects; liraglutide formulations; bioequivalence ... See more keywords
Bioequivalence and Pharmacokinetic Profiles of 2 Trimetazidine Modified‐release Tablets Under Fasting and Fed Conditions in Chinese Healthy Subjects
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DOI: 10.1002/cpdd.1200
Abstract: This study aims to assess the bioequivalence of test and reference formulations of trimetazidine dihydrochloride in healthy Chinese volunteers under fasting and fed conditions, and to determine the effect of food on the pharmacokinetic profiles… read more here.
Keywords: fasting fed; fed conditions; profiles trimetazidine; bioequivalence ... See more keywords
Evaluation of Pharmacokinetics and Safety With Bioequivalence of Voriconazole Injection of 2 Formulations in Chinese Healthy Volunteers: Bioequivalence Study
Sign Up to like & getrecommendations! Published in 2023 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1218
Abstract: Voriconazole is a first‐line medicine for treating invasive aspergillosis. We aimed to evaluate the bioequivalence (BE) of voriconazole injection in Chinese healthy volunteers (HVs). In this single‐center, randomized, single‐dose, 2‐cycle, fasting‐dose BE study, HVs (n… read more here.
Keywords: time; bioequivalence voriconazole; concentration; voriconazole injection ... See more keywords