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A Bioavailability Study of Methotrexate 25 mg Administered by Needle Injection and a Pre Filled Needle-free Device in Healthy Volunteers.

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ClinicalTrials.gov Identifier: NCT03103334
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Crossject

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.

Condition or disease Intervention/treatment Phase
Healthy Other: Zeneo® - Methotrexate Drug: Methotrexate Biodim® Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : June 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental A
Zeneo® - Methotrexate thigh to Methotrexate Biodim® thigh
Other: Zeneo® - Methotrexate
0.625 mL of methotrexate solution 40 mg/ML for subcutaneous injection with a prefilled and needle-free delivery system

Drug: Methotrexate Biodim®
1 mL of methotrexate solution 25 mg/mL for subcutaneous injection with a conventional needle and syringe injection

Experimental: Experimental B
Methotrexate Biodim® thigh to Zeneo® - Methotrexate thigh
Other: Zeneo® - Methotrexate
0.625 mL of methotrexate solution 40 mg/ML for subcutaneous injection with a prefilled and needle-free delivery system

Drug: Methotrexate Biodim®
1 mL of methotrexate solution 25 mg/mL for subcutaneous injection with a conventional needle and syringe injection

Experimental: Experimental C
Zeneo® - Methotrexate abdomen to Methotrexate Biodim® abdomen
Other: Zeneo® - Methotrexate
0.625 mL of methotrexate solution 40 mg/ML for subcutaneous injection with a prefilled and needle-free delivery system

Drug: Methotrexate Biodim®
1 mL of methotrexate solution 25 mg/mL for subcutaneous injection with a conventional needle and syringe injection

Experimental: Experimental D
Methotrexate Biodim® abdomen to Zeneo® - Methotrexate abdomen
Other: Zeneo® - Methotrexate
0.625 mL of methotrexate solution 40 mg/ML for subcutaneous injection with a prefilled and needle-free delivery system

Drug: Methotrexate Biodim®
1 mL of methotrexate solution 25 mg/mL for subcutaneous injection with a conventional needle and syringe injection




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Responsible Party: Crossject
ClinicalTrials.gov Identifier: NCT03103334     History of Changes
Other Study ID Numbers: L9-E-CJT-CM-131003
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors