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
Pharmacokinetics and Bioequivalence of Single‐Oral‐Dose Linagliptin: A Randomized, 2‐Period Crossover Trial in Chinese Healthy Subjects Under Fasting and Fed Conditions
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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
Pharmacokinetics and Bioequivalence of 2 Safinamide Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions
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DOI: 10.1002/cpdd.1157
Abstract: To assess the bioequivalence of a generic safinamide tablet (test) vs a brand‐name safinamide tablet (reference) and effects of food on the pharmacokinetics of safinamide in healthy Chinese subjects, a single‐center, single‐dose, randomized, open‐label, 2‐preparation,… read more here.
Keywords: time; fasting fed; chinese volunteers; fed conditions ... See more keywords
Pharmacokinetic and Bioequivalence Study of Eldecalcitol Soft Capsules in Healthy Chinese Subjects
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DOI: 10.1002/cpdd.1159
Abstract: Eldecalcitol is a novel active vitamin D3 1,25(OH)2D3 derivative used in the treatment of osteoporosis. To investigate and compare the pharmacokinetic and bioequivalent profiles of two eldecalcitol soft capsule formulations at a single dose of… read more here.
Keywords: chinese subjects; fed conditions; eldecalcitol soft; soft capsules ... See more keywords
Pharmacokinetics, Bioequivalence, and Safety of 2 Formulations of Hydroxychloroquine Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions
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DOI: 10.1002/cpdd.1166
Abstract: The purpose of this trial was to evaluate the pharmacokinetics (PK), bioequivalence (BE), and safety of 2 preparations of hydroxychloroquine (200‐mg tablet) under fasting and fed conditions. A total of 180 subjects (fasting condition: n… read more here.
Keywords: safety; fasting fed; pharmacokinetics bioequivalence; fed conditions ... 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
Pharmacokinetics, Bioequivalence, and Safety Evaluation of Dienogest in Healthy Subjects Under Fasting and Fed Conditions
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DOI: 10.1002/cpdd.1215
Abstract: Dienogest is effective in reducing endometriosis‐related pain symptoms. This study aims to investigate and compare the pharmacokinetic profiles and safety of test formulations to reference formulations of dienogest in healthy Chinese female volunteers under fasting… read more here.
Keywords: time; safety; fasting fed; concentration ... See more keywords
Pharmacokinetic and Bioequivalence Studies of 2 Metformin Glibenclamide Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions
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DOI: 10.1002/cpdd.1219
Abstract: The rational combination of oral antidiabetic agents is more likely to provide better glycemic control than monotherapy. Metformin glibenclamide tablets can be used as second‐line therapy for patients with type 2 diabetes mellitus who cannot… read more here.
Keywords: time; fasting fed; fed conditions; glibenclamide tablets ... See more keywords
Physiologically Based Dissolution Testing in a Drug Development Process—a Case Study of a Successful Application in a Bioequivalence Study of Trazodone ER Formulations Under Fed Conditions
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DOI: 10.1208/s12249-020-01662-8
Abstract: Development of generic extended-release (ER) formulations is challenging. Especially under fed conditions, the risk of failure in bioequivalence trials is high because of long gastric residence times and susceptibility to food effects. We describe the… read more here.
Keywords: bioequivalence; fed conditions; trazodone; study ... See more keywords
Pharmacokinetics of a Fixed-Dose Combination of Teneligliptin Hydrochloride Hydrate and Modified-Release Metformin Under Fasting and Fed Conditions in Healthy Subjects
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DOI: 10.2147/dddt.s393675
Abstract: Purpose This study was performed to compare the pharmacokinetics of two fixed-dose combination (FDC) formulations of teneligliptin combined with modified-release metformin in healthy Korean subjects under fasting and fed conditions. Patients and Methods The study… read more here.
Keywords: fasting fed; modified release; fixed dose; fed conditions ... See more keywords