Short Duration of Antenatal Corticosteroid Exposure and Outcomes in Extremely Preterm Infants
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DOI: 10.1001/jamanetworkopen.2024.61312
Abstract: Key Points Question What is the minimum duration of exposure to a single dose of antenatal betamethasone associated with improved neonatal survival and reduced morbidities? Findings In this cohort study among 1806 infants born extremely… read more here.
Keywords: duration; single dose; short duration; extremely preterm ... See more keywords
Efficient Single‐Dose Induction of Osteogenic Differentiation of Stem Cells Using Multi‐Bioactive Hybrid Nanocarriers
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DOI: 10.1002/adbi.202000123
Abstract: Bone regeneration requires the presence of specific factors to induce the differentiation of stem cells into osteoblasts. These factors induce osteogenesis by stimulating the expression of bone‐related proteins, bone cell proliferation and differentiation. Herein, bioactive… read more here.
Keywords: stem cells; differentiation; differentiation stem; osteogenic differentiation ... See more keywords
Bioequivalence of Esaxerenone Conventional Tablet and Orally Disintegrating Tablet: Two Single‐Dose Crossover Studies in Healthy Japanese Men
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DOI: 10.1002/cpdd.1087
Abstract: We assessed the bioequivalence of a single dose of 5‐mg of esaxerenone administered as an orally disintegrating tablet (ODT) with the conventional oral tablet in healthy Japanese men. This single‐center, open‐label, randomized, two‐drug, two‐stage crossover,… read more here.
Keywords: single dose; orally disintegrating; tablet; disintegrating tablet ... 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
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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 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
Comparative Bioavailability of a Single Dose of Trametinib (TMT212) Containing 9% vs 11% Dimethyl Sulfoxide in Randomized Healthy Volunteers to Assess Long‐Term Storage at Room Temperature
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DOI: 10.1002/cpdd.1129
Abstract: Storage of trametinib tablets outside of 2‐8°C protected from moisture may lead to loss of dimethyl sulfoxide (DMSO) and adversely impact trametinib bioavailability. In this open‐label, phase 1, single‐dose, randomized, 2‐treatment, 2‐period crossover study in… read more here.
Keywords: single dose; healthy volunteers; bioavailability; trametinib ... See more keywords
Bioequivalence of Pomalidomide Capsules in Fasting and Fed States in Healthy Male Volunteers: A Randomized, Open, Single‐Dose, Biperiodic, Double‐Crossover Study
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DOI: 10.1002/cpdd.1173
Abstract: This study evaluated the safety, pharmacokinetic parameters, and bioequivalence (BE) of pomalidomide (POM) capsules (specification: 4 mg) acquired from 2 sponsors (test [T] and reference [R]), under fasting and fed conditions. A single‐center, randomized, open‐label,… read more here.
Keywords: single dose; fasting fed; fed states; concentration ... See more keywords
Effect of a High‐Fat Meal on Single‐Dose Rencofilstat (CRV431) Oral Bioavailability in Healthy Human Subjects
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DOI: 10.1002/cpdd.1179
Abstract: Rencofilstat (RCF) is a novel cyclophilin inhibitor under development for the treatment of nonalcoholic steatohepatitis and hepatocellular carcinoma. This phase 1, randomized, open‐label study in healthy participants assessed the relative bioavailability of a single dose… read more here.
Keywords: single dose; fat meal; high fat; bioavailability ... 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
Pharmacokinetics and Bioequivalence of the Lubiprostone Capsule in Healthy Chinese Subjects
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DOI: 10.1002/cpdd.1212
Abstract: A pharmacokinetic (PK) study and a bioequivalence (BE) study were conducted to investigate the PK characteristics and safety of lubiprostone in healthy Chinese subjects and to evaluate the BE between the test and the reference… read more here.
Keywords: single dose; state; chinese subjects; lubiprostone ... See more keywords
Bioequivalence and Tolerability of 2 Lurasidone Formulations: A Randomized, Single‐Dose, 2‐Period, Crossover Study in Healthy Chinese Subjects Under Fasting and Fed Conditions
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DOI: 10.1002/cpdd.1529
Abstract: Lurasidone is utilized in the treatment of schizophrenia and bipolar depression in adults and adolescents. In this work, a randomized, single‐dose, 2‐period crossover study was designed and conducted to evaluate the bioequivalence and safety of… read more here.
Keywords: single dose; healthy chinese; lurasidone; chinese subjects ... See more keywords