scholarly journals Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects

2021 ◽  
Author(s):  
Hidetoshi Shimizu ◽  
Yukiko Nishimura ◽  
Youichi Shiide ◽  
Kaori Yoshida ◽  
Manabu Hirai ◽  
...  
Keyword(s):  
Healthy Adult ◽  
Bioequivalence Study ◽  
Oral Suspension ◽  
Intravenous Formulation

A Single-Dose, Two-Way Crossover, Open-Label Bioequivalence Study of an Amphetamine Extended-Release Oral Suspension in Healthy Adults

2017 ◽  
Vol 24 (3) ◽  
pp. 414-419 ◽  
Author(s):  
Carolyn Sikes ◽  
Jeffrey G. Stark ◽  
Russ McMahen ◽  
Dorothy Engelking
Keyword(s):  
Single Dose ◽  
Extended Release ◽  
Healthy Adult ◽  
Bioequivalence Study ◽  
Oral Suspension ◽  
Pharmacokinetic Parameters ◽  
Open Label ◽  
Adult Participants ◽  
Study Results ◽  
Adult Volunteers

Objective: The purpose of this study was to compare the pharmacokinetics of a new extended-release amphetamine oral suspension (AMP XR-OS) with a standard extended-release mixed amphetamine salts product, Adderall XR®. Method: In this single-dose, open-label, randomized, two-period, two-treatment crossover study, 42 healthy adult volunteers received 15 mL of AMP XR-OS in one period and a 30 mg Adderall XR capsule in another period (both containing 18.8 mg of amphetamine base) under fasted conditions. Blood samples were analyzed for d- and l-amphetamine concentrations, and pharmacokinetic parameters Cmax, AUC0-5, AUC5-last, and AUCinf were calculated to determine bioequivalence. Safety was monitored throughout the study. Results: The 90% confidence intervals (CIs) for the log-transformed Cmax, AUC0-5, AUC5-last, and AUCinf fell within the accepted 80% to 125% range for establishing bioequivalence for d- and l-amphetamine. The most common adverse events were nausea and decreased appetite. Conclusion: AMP XR-OS is bioequivalent to Adderall XR in healthy adult participants.

Bioequivalence study with lapatinib powder for oral suspension and the original tablet formulation in cancer patients

2014 ◽  
Vol 4 (3) ◽  
pp. 203-209
Author(s):  
Kevin M. Koch ◽  
Geraldine Ferron-Brady ◽  
Colleen Lemmon ◽  
Leanne Cartee ◽  
Hedy Hollyfield ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Bioequivalence Study ◽  
Tablet Formulation ◽  
Oral Suspension

A bioequivalence study of proposed bevacizumab biosimilar, MYL-1402O (A) vs EU-Avastin (B) and US-Avastin (C).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14034-e14034 ◽  
Author(s):  
Mark A. Socinski ◽  
Matthew Hummel ◽  
Tjerk Bosje ◽  
Andrew Shaw ◽  
Mark Shiyao Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Healthy Adult ◽  
Bioequivalence Study ◽  
Primary Objective ◽  
Double Blind ◽  
Safety Issues ◽  
Parallel Group ◽  
Healthy Adult Male ◽  
To Receive ◽  
Clinical Trial Information

e14034 Background: MYL-1402O is a proposed bevacizumab biosimilar. The similarity of MYL-1402O to Avastin has been demonstrated in physicochemical analyses, and nonclinical studies. Methods: This single-center, randomized, double blind, three-arm, parallel-group, study was conducted in healthy adult male volunteers. The primary objective of this study was to establish PK similarity of A to B and C, and B to C. Subjects were randomized to receive either A, B or C 1 mg/kg over 90 minutes as an intravenous infusion. Dose was selected based on the lower dose in the linear range of PK and acceptable safety in healthy volunteers. Bioequivalence was to be concluded if the 90% CIs of the ratios (A/B, A/C and B/C) of LS means of the natural log transformed AUC0-inf were within 80% to 125%. AUC0-t, Cmax, tmax, kel and t½ were assessed as secondary PK parameters. Results: A total of 111 subjects (37/treatment) were enrolled and 110 [37 (A), 36 (B), 37(C)] were included in the analysis. Bioequivalence was demonstrated between A and B, A and C and between B and C. LS mean ratios were close to 1, and 90% CIs were within 0.80 to 1.25 for all of the comparisons. The secondary PK parameters were also comparable with the 90% CIs for ratios of AUC0-t and Cmax within 80%-125%. A total of 313 TEAEs were reported, 116 by 33 (89%) subjects who received A, 99 by 29 (78%) subjects who received B and 98 by 28 (76%) subjects who received C. Most TEAEs were consistent with the clinical data of bevacizumab (Avastin). No serious or unexpected TEAEs were reported. TEAEs were grade 1 or grade 2 in severity. The anti-drug antibodies are being evaluated (pending results). Conclusions: These results confirm bioequivalence of Myl-1402O vs. EU-Avastin and US-Avastin. All treatments were well tolerated and no significant safety issues emerged. Clinical trial information: NCT02469987 Clinical trial information: NCT02469987.

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