- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03168022
Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers.
A SINGLE-DOSE, RANDOMIZED, OPEN-LABEL, TWO-WAY CROSSOVER BIOEQUIVALENCE STUDY OF TNX-102 SL (CYCLOBENZAPRINE HCL SUBLINGUAL TABLETS) 2.8 mg FROM TWO MANUFACTURERS IN HEALTHY SUBJECTS UNDER FASTING CONDITIONS
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This will be a single centre, bioequivalence, open-label, randomized, single-dose, 2-period, 2 sequence, crossover study under fasting conditions.
Potential subjects will be screened by medical and psychiatric history, and laboratory and physical examinations 2 to 30 days prior to drug administration. All eligible subjects will be admitted to the study unit on Day -1, the day prior to dose administration. Baseline values will be considered the last value obtained before dosing for each assessment. On Day 1, the morning after admission, after all pre-dose assessments have been completed and subjects who remain eligible have agreed to continue, subjects will be randomly assigned to study medication and will receive the assigned test drug. Subjects will be required to fast for at least 10 hours prior to dosing until at least 4 hours post-dose.
For each period, subjects will be confined to the study site from at least 10 hours before dosing until after the 24-hour post-dose blood draw. Subjects will come back for all subsequent blood draws. Subjects will be reassessed for eligibility prior to each dosing period.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Quebec, Canada, GIP )A2
- inVentiv Health Clinique Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male or female between 18 and 65 years of age, non-smoker.
- Body mass index >18.5 and <30.0 kg/m2
- Females of childbearing potential must be willing to use a medically acceptable method of birth control throughout the study.
- Capable of consent.
Exclusion Criteria:
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening
- Positive hepatitis B, hepatitis C, HIV, urine drug screen, urine cotinine test, or alcohol breath test at screening.
- History of hypersensitivity to cyclobenzaprine, any of the formulation component, or other related drugs.
- Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration.
- Positive pregnancy test at screening.
- Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities at screening.
- History of significant alcohol or drug abuse within one year prior to screening
- 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.
- Use of medication other than topical products without significant systemic absorption and hormonal contraceptives
- Breast-feeding subject.
- Presence of dentures, tongue piercings with ongoing use of tongue studs/jewelry, orthodontic braces, or surgical manipulations of the tongue.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment A
1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved.
|
1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved.
Other Names:
|
Experimental: Treatment B
1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved.
|
1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Plasma Concentration (AUC) of Cyclobenzaprine
Time Frame: 0 to 96 hours
|
Blood samples were collected prior to drug administration and 0.083 (5 min), 0.167 (10 min),0.333
(20 min), 0.500 (30 min), 0.750 (45 min), 1.00, 1.50, 2.00, 2.50, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 5.50, 6.00, 8.00, 12.0, 16.0, 24.0, 36.0,
48.0, 72.0, and 96.0 hours post-dose in each period.
|
0 to 96 hours
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Treatment A and Treatment B, Administered as 1 x 2.8 mg TNX-102 SL Under Fasting Conditions.
Time Frame: Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month)
|
The MedDRA® dictionary was used to classify all TEAEs reported during the study by System Organ Class (SOC) and Preferred Term (PT).
|
Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Denis Audet, MD, inVentiv
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Tranquilizing Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Neuromuscular Agents
- Adrenergic Uptake Inhibitors
- Muscle Relaxants, Central
- Amitriptyline
- Cyclobenzaprine
Other Study ID Numbers
- TNX-CY-F105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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