scholarly journals A Randomized, Single‐Blind, Placebo‐Controlled, 3‐Way Crossover Study to Evaluate the Effect of Therapeutic and Supratherapeutic Doses of Edaravone on QT/QTc Interval in Healthy Subjects

2020 ◽  
Author(s):  
Hidetoshi Shimizu ◽  
Shinsuke Inoue ◽  
Mai Endo ◽  
Yoshinobu Nakamaru ◽  
Kaori Yoshida ◽  
...  
Keyword(s):  
Crossover Study ◽  
Healthy Subjects ◽  
Qtc Interval ◽  
Single Blind

scholarly journals Bioequivalence evaluation of two oral formulations of Dexketoprofen-trometamol (solution and tablets) in healthy subjects: Results from a randomized, single-blind, crossover study

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Jorge González-Canudas ◽  
Luis Jesús García-Aguirre ◽  
Araceli Medina-Nolasco ◽  
María Isabel Ruíz-Olmedo ◽  
Liz Janet Medina Reyes ◽  
...  
Keyword(s):  
Crossover Study ◽  
Healthy Subjects ◽  
Oral Formulations ◽  
Dexketoprofen Trometamol ◽  
Single Blind ◽  
Blind Crossover Study

scholarly journals Bioequivalence Evaluation of Two Oral Formulations of Acetaminophen in Healthy Subjects: Results From a Randomized, Single‐Blind, Crossover Study

2018 ◽  
Vol 8 (1) ◽  
pp. 9-15
Author(s):  
Luis García Aguirre ◽  
Carlos Bohorquez Nassar ◽  
Isabel Ruiz Olmedo ◽  
Lara Dennie ◽  
Araceli G. Medina Nolasco
Keyword(s):  
Crossover Study ◽  
Healthy Subjects ◽  
Oral Formulations ◽  
Single Blind ◽  
Blind Crossover Study

Randomized, single-blind, crossover study to assess the pharmacokinetic and pharmacodynamic bioequivalence of CHS-1701 to pegfilgrastim in healthy subjects.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21693-e21693 ◽  
Author(s):  
John A. Glaspy ◽  
Paula G. O'Connor ◽  
Hong Tang ◽  
Barbara Finck
Keyword(s):  
Crossover Study ◽  
Healthy Subjects ◽  
Geometric Mean ◽  
Area Under The Curve ◽  
Treatment Groups ◽  
Single Blind ◽  
Stimulating Factor ◽  
Clinical Trial Information ◽  
Pegylated Form ◽  
Treatment Sequences

e21693 Background: CHS-1701 is a proposed biosimilar of pegfilgrastim, a pegylated form of recombinant human granulocyte colony stimulating factor approved for decreasing infection in patients receiving myelosuppressive anticancer drugs associated with febrile neutropenia. This multi-center, randomized, single-blind, 3-sequence, crossover study in healthy subjects assessed bioequivalence of CHS-1701 to pegfilgrastim with regard to pharmacokinetics (PK) and pharmacodynamics (PD). Methods: Subjects were randomized to 1 of 3 treatment sequences; each included 1 dose of CHS-1701 (6-mg) and 2 doses of pegfilgrastim (6-mg) separated by ≥28 days. Primary PK endpoints were area under the curve from 0 to infinity (AUC0-∞) and maximum concentration (Cmax). PD endpoints were maximum absolute neutrophil count (ANCmax) and ANC area under the curve (ANC AUCs). Bioequivalence was demonstrated if the 90% confidence interval (CI) for the geometric mean ratio (GMR) of CHS-1701 to pegfilgrastim was within 80-125% for the endpoints. Results: 122 subjects were randomized and treated. Baseline characteristics were comparable between treatment groups. Median age was 29.5 (range 18-45). PK bioequivalence criteria were met for Cmax (GMR = 105.0; 90% CI 95.5, 115.4) and AUC0–∞ (GMR = 97.5; 90% CI 88.6, 107.2). PD bioequivalence criteria were met for ANCmax (GMR = 99.6; 90% CI: 96.2, 103.2), ANC AUC0–last (GMR = 96.7; 90% CI: 92.2, 101.4), and ANC AUC0–480 (GMR = 99.8; 90% CI: 97.7, 102.0). Adverse events (AEs) occurred in 76.0%, 76.6%, and 73.1% of subjects during the CHS-1701, first pegfilgrastim, and second pegfilgrastim dosing periods across treatment sequences, respectively. Investigator-designated treatment-related AEs occurred in 71.9%, 71.2%, and 62.8% of subjects, respectively, and most commonly included back pain (47.9%, 42.3%, 33.3%) and headache (33.3%, 41.4%, 34.6%). There were no treatment-related serious AEs. Conclusions: This study established the bioequivalence of CHS-1701 to pegfilgrastim with respect to PK and PD. There were no unexpected safety findings, and the two treatments displayed similar safety profiles. Clinical trial information: NCT02650973.

Randomized, Blinded, Placebo- and Positive-Controlled Crossover Study to Determine the Effect of Deferiprone on the QTc Interval in Healthy Subjects

2017 ◽  
Vol 7 (1) ◽  
pp. 22-32 ◽  
Author(s):  
Caroline Fradette ◽  
Anna Rozova ◽  
Anne Stilman ◽  
Yu Chung Tsang ◽  
Mark J. Allison ◽  
...  
Keyword(s):  
Crossover Study ◽  
Healthy Subjects ◽  
Qtc Interval

Influence of Vitamin E on Plasma Malondialdehyde- Like Material in Man

1984 ◽  
Vol 51 (03) ◽  
pp. 347-348 ◽  
Author(s):  
C Cordova ◽  
A Musca ◽  
F Violi ◽  
C Alessandri ◽  
A Ghiselli ◽  
...  
Keyword(s):  
Vitamin E ◽  
Healthy Subjects ◽  
Placebo Treatment ◽  
Blind Study ◽  
Single Blind ◽  
Plasma Malondialdehyde

SummaryThe behaviour of plasma malondialdehyde-like material (MDA-LM) was evaluated in 13 healthy subjects by a single-blind study that consisted of placebo (30 days), vitamin E treatment (300 mg/day) (30 days) and placebo (30 days). The study demonstrated that MDA-LM did not change during placebo treatment while it significantly decreased after vitamin E administration.

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