A Phase 1 interventional study of Zeneo® - Methotrexate and Methotrexate Biodim® in Healthy, sponsored by Crossject. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-16.
Sponsored by Crossject · Phase 1, Interventional, and Treatment
The objective is to determine whether the test product, Methotrexate 40 mg/mL solution for injection administered subcutaneously by the prefilled and needle-free delivery system Zeneo®, and the reference product, Methotrexate Biodim® 25 mg/mL, solution for injection administered subcutaneously by a conventional syringe with needle are bioequivalent.
ABSTRACT Objective: Zeneo1 is a needle-free injection device. We performed a pharmacokinetic study to investigate the bioequivalence of methotrexate administered subcutaneously using either the needle-free injection device or a conventional needle and syringe.
Research design and methods: This was a single-dose, open-label, laboratory-blind, randomized crossover study performed in adult healthy volunteers. Each participant received two methotrexate injections (each 25mg), one via needle-free injection device and one via conventional injection, with a 21-28 day wash-out interval between dosing. For each participant, the administration site for both injections was either the abdomen or the thigh.
Main outcome measures: The primary pharmacokinetic outcome parameters were AUC(0-t) and Cmax.
Bioequivalence was assessed by standard criteria: whether 90% confidence intervals of geometric mean ratios for the two administration methods were within 80-125%.
Results: Fifty-two individuals completed the study. Bioequivalence criteria were met for AUC(0-t), for the overall analysis (both injection sites: 90% confidence interval: 99.4-103.1%), and for each injection site separately. Bioequivalence was similarly demonstrated with AUC(0-1). Bioequivalence criteria for Cmax were fulfilled for abdominal administration but not for the overall analysis. Injection via the needle- free injection device was well tolerated.
Limitations: Limitations include conducting the study in healthy volunteers and the relatively small subject number (albeit satisfactory for bioequivalence).
Conclusions: This study shows that methotrexate injection via needle-free injection device is bioequivalent to a conventional needle and syringe in relation to AUC(0-t) and AUC(0-1). Studies of needle-free injection device use in patients requiring methotrexate therapy are planned.
Crossject is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Zeneo® - Methotrexate thigh to Methotrexate Biodim® thigh
Other: Zeneo® - Methotrexate · Drug: Methotrexate Biodim®
Methotrexate Biodim® thigh to Zeneo® - Methotrexate thigh
Other: Zeneo® - Methotrexate · Drug: Methotrexate Biodim®
Zeneo® - Methotrexate abdomen to Methotrexate Biodim® abdomen
Other: Zeneo® - Methotrexate · Drug: Methotrexate Biodim®
Methotrexate Biodim® abdomen to Zeneo® - Methotrexate abdomen
Other: Zeneo® - Methotrexate · Drug: Methotrexate Biodim®
0.625 mL of methotrexate solution 40 mg/ML for subcutaneous injection with a prefilled and needle-free delivery system
1 mL of methotrexate solution 25 mg/mL for subcutaneous injection with a conventional needle and syringe injection
Maximum observed plasma concentration (Cmax).
Time frame: serial pharmacokinetic plasma concentrations were drawn prior pre-dose and post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours
Area under the plasma concentration versus time curve (AUC) time zero to time of the last quantifiable concentration (AUC(0-t)).
Time frame: serial pharmacokinetic plasma concentrations were drawn prior pre-dose and post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours
No study locations are listed for this record.
Plan to share: No
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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