A Bioavailability Study of Methotrexate 25 mg Administered by Needle Injection and a Pre Filled Needle-free Device in Healthy Volunteers.
A Single Center Single Dose Open-label Randomized Two Period Crossover Study to Determine the Bioavailability of Two Formulations of Methotrexate 25 mg Administered by Needle Injection and a Pre-filled Needle-free Device in at Least 48 Healthy Volunteers.
1 other identifier
interventional
58
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jun 2014
Typical duration for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 31, 2017
CompletedFirst Posted
Study publicly available on registry
April 6, 2017
CompletedFebruary 16, 2021
February 1, 2021
3 months
March 31, 2017
February 12, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum observed plasma concentration (Cmax).
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)).
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
Study Arms (4)
Experimental A
EXPERIMENTALZeneo® - Methotrexate thigh to Methotrexate Biodim® thigh
Experimental B
EXPERIMENTALMethotrexate Biodim® thigh to Zeneo® - Methotrexate thigh
Experimental C
EXPERIMENTALZeneo® - Methotrexate abdomen to Methotrexate Biodim® abdomen
Experimental D
EXPERIMENTALMethotrexate Biodim® abdomen to Zeneo® - Methotrexate abdomen
Interventions
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
Eligibility Criteria
You may qualify if:
- Healthy subjects
- BMI between 18.5 and 30 kg/m2
- Body mass \> 60 kg
- Non-tobacco user
- Written consent given for participation in the study
You may not qualify if:
- Evidence of clinically relevant oral, cardiovascular, hematologic, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorder
- Heavy alcohol consumption and regular exposure to drug of abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Crossjectlead
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2017
First Posted
April 6, 2017
Study Start
June 1, 2014
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
February 16, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share