Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT03103334
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2017-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Bioavailability Study of Methotrexate 25 mg Administered by Needle Injection and a Pre Filled Needle-free Device in Healthy Volunteers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-12', 'studyFirstSubmitDate': '2017-03-31', 'studyFirstSubmitQcDate': '2017-03-31', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax).', 'timeFrame': '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'}, {'measure': 'Area under the plasma concentration versus time curve (AUC) time zero to time of the last quantifiable concentration (AUC(0-t)).', 'timeFrame': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nResearch 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.\n\nMain outcome measures: The primary pharmacokinetic outcome parameters were AUC(0-t) and Cmax.\n\nBioequivalence was assessed by standard criteria: whether 90% confidence intervals of geometric mean ratios for the two administration methods were within 80-125%.\n\nResults: 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.\n\nLimitations: Limitations include conducting the study in healthy volunteers and the relatively small subject number (albeit satisfactory for bioequivalence).\n\nConclusions: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects\n* BMI between 18.5 and 30 kg/m2\n* Body mass \\> 60 kg\n* Non-tobacco user\n* Written consent given for participation in the study\n\nExclusion Criteria:\n\n* Evidence of clinically relevant oral, cardiovascular, hematologic, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorder\n* Heavy alcohol consumption and regular exposure to drug of abuse'}, 'identificationModule': {'nctId': 'NCT03103334', 'briefTitle': 'A Bioavailability Study of Methotrexate 25 mg Administered by Needle Injection and a Pre Filled Needle-free Device in Healthy Volunteers.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Crossject'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'L9-E-CJT-CM-131003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental A', 'description': 'Zeneo® - Methotrexate thigh to Methotrexate Biodim® thigh', 'interventionNames': ['Other: Zeneo® - Methotrexate', 'Drug: Methotrexate Biodim®']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental B', 'description': 'Methotrexate Biodim® thigh to Zeneo® - Methotrexate thigh', 'interventionNames': ['Other: Zeneo® - Methotrexate', 'Drug: Methotrexate Biodim®']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental C', 'description': 'Zeneo® - Methotrexate abdomen to Methotrexate Biodim® abdomen', 'interventionNames': ['Other: Zeneo® - Methotrexate', 'Drug: Methotrexate Biodim®']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental D', 'description': 'Methotrexate Biodim® abdomen to Zeneo® - Methotrexate abdomen', 'interventionNames': ['Other: Zeneo® - Methotrexate', 'Drug: Methotrexate Biodim®']}], 'interventions': [{'name': 'Zeneo® - Methotrexate', 'type': 'OTHER', 'description': '0.625 mL of methotrexate solution 40 mg/ML for subcutaneous injection with a prefilled and needle-free delivery system', 'armGroupLabels': ['Experimental A', 'Experimental B', 'Experimental C', 'Experimental D']}, {'name': 'Methotrexate Biodim®', 'type': 'DRUG', 'description': '1 mL of methotrexate solution 25 mg/mL for subcutaneous injection with a conventional needle and syringe injection', 'armGroupLabels': ['Experimental A', 'Experimental B', 'Experimental C', 'Experimental D']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Crossject', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}