Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT03443960
Status:
COMPLETED
Last Update Posted:
2018-04-24
First Post:
2018-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C004704', 'term': 'cyclobenzaprine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-23', 'studyFirstSubmitDate': '2018-02-06', 'studyFirstSubmitQcDate': '2018-02-21', 'lastUpdatePostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Steady-State Area Under the Plasma Concentration Versus Time Curve (AUC-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg', 'timeFrame': 'Day 1 to Day 27', 'description': 'Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-last dose).'}, {'measure': 'Peak Steady-State Plasma Concentration (Cmax-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg', 'timeFrame': 'Day 1 to Day 27', 'description': 'Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-dose).'}, {'measure': 'Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg versus AMRIX 30 mg', 'timeFrame': 'Day 1 to Day 47', 'description': 'TEAEs will be collected throughout the study and are summarized descriptively by treatment, relationship, and severity for all subjects dosed.'}, {'measure': 'Peak Steady-State Plasma Concentration (Cmax-ss) of norcyclobenzaprine from TNX-102 SL 5.6 mg versus AMRIX 30 mg', 'timeFrame': 'Day 1 to Day 47', 'description': 'Blood samples are collected from pre-dose on Day 1 up until Day 47 (648 hours post-last dose).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This will be a single center, comparative pharmacokinetic, open-label, randomized, multiple-dose, 1-period, 2-arm, parallel study of TNX-102 SL 5.6 mg (administered as 2 x 2.8 mg tablets) to AMRIX® (cyclobenzaprine hydrochloride \\[HCl\\] extended-release \\[ER\\] capsules), 30 mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, non-smoker, ≥18 and ≤75 years of age (Treatment A) or ≥18 and ≤65 years of age (Treatment B), with Body Mass Index (BMI) \\>18.5 and \\<30.0 kg/m2\n* Females of childbearing potential must be willing to use a medically acceptable method of birth control throughout the study\n* Capable of consent\n\nExclusion Criteria:\n\n* Any clinically significant abnormality or abnormal laboratory test results found during medical screening\n* Positive hepatitis B, hepatitis C, HIV, urine drug screen, urine cotinine test, or alcohol breath test at screening\n* History of allergic reactions to cyclobenzaprine, any of the formulation component, or other related drugs\n* Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration\n* Positive pregnancy test at screening\n* Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities at screening\n* History of significant alcohol or drug abuse within one year prior to screening\n* Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days prior to the first dosing or concomitant participation in an investigational study involving no drug administration\n* Use of medication other than topical products without significant systemic absorption and hormonal contraceptives\n* Donation of plasma within 7 days prior to dosing, or significant loss of blood within 54 days of dosing.\n* Abnormal hemoglobin and hematocrit levels at screening\n* Breast-feeding subject\n* Presence of dentures, tongue piercings with ongoing use of tongue studs/jewelry, orthodontic braces, or surgical manipulations of the tongue'}, 'identificationModule': {'nctId': 'NCT03443960', 'briefTitle': 'Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tonix Pharmaceuticals, Inc.'}, 'officialTitle': 'A Multiple-Dose, Randomized, Open-Label, Parallel Pharmacokinetic Comparison Study of TNX-102 SL (Cyclobenzaprine Hydrochloride [HCl] Sublingual Tablets) 2 x 2.8 mg Versus AMRIX® (Cyclobenzaprine HCl ER Capsules) 30 mg in Healthy Subjects Under Fasting Conditions', 'orgStudyIdInfo': {'id': 'TNX-CY-F106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A (TNX-102 SL)', 'description': '2 x TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg once daily for 20 consecutive days', 'interventionNames': ['Drug: TNX-102 SL 5.6 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment B (AMRIX)', 'description': '1 x AMRIX ER capsule 30 mg once daily for 20 consecutive days', 'interventionNames': ['Drug: Amrix 30 mg']}], 'interventions': [{'name': 'TNX-102 SL 5.6 mg', 'type': 'DRUG', 'otherNames': ['cyclobenzaprine HCl'], 'description': 'Subjects randomly assigned to this treatment will place 2 tablets simultaneously under the tongue until dissolved, and not to crush or chew them.', 'armGroupLabels': ['Treatment A (TNX-102 SL)']}, {'name': 'Amrix 30 mg', 'type': 'DRUG', 'otherNames': ['cyclobenzaprine HCl'], 'description': 'Subjects randomly assigned to this treatment will swallow 1 capsules with a cup of water, and not to crush or chew it.', 'armGroupLabels': ['Treatment B (AMRIX)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1P 0A2', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Quebec City', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tonix Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}