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Trial record 9 of 46 for:    CYCLOBENZAPRINE

A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.

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ClinicalTrials.gov Identifier: NCT01490788
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : November 2, 2018
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: Treatment A
Drug: Treatment B
Drug: Treatment C
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment A First, Then B, Then C Treatment A First, Then C, Then B Treatment B First, Then A, Then C Treatment B First, Then C, Then A Treatment C First, Then A, Then B Treatment C First, Then B, Then A
Hide Arm/Group Description Single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions) Single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions) Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions) Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions) Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions) Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions)
Period Title: Overall Study
Started 5 5 5 5 5 5
Completed 4 5 5 5 5 5
Not Completed 1 0 0 0 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description All subjects that were randomized to receive all three treatments.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
8
  26.7%
Male
22
  73.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 30 participants
30
1.Primary Outcome
Title Mean Plasma Concentration (AUC) of Cyclobenzaprine
Hide Description Blood samples were collected pre-dose, 30 min, 1, 1.5, 2, 2.5, 3, 3.33, 3.67, 4, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose for each treatment period.
Time Frame 0 to 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
All study subject who were administered one TNX-102 2.4 mg gelcap under fasting conditions during the course of the study.
All study subject who were administered one IR tablet of cyclobenzaprine 5 mg under fasting conditions during the course of the study.
All study subject who were administered one TNX-102 2.4 mg, gelcap under fed conditions during the course of the study.
Overall Number of Participants Analyzed 30 30 30
Mean (Full Range)
Unit of Measure: pg.hr/mL
47,074.19
(30288.11 to 63860.27)
94,874.26
(60588.45 to 129160.07)
50,263.16
(30725.75 to 69800.57)
2.Primary Outcome
Title Incidences of Adverse Events
Hide Description Every adverse events occurring during the study period will be reported.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
All study subject who were administered one TNX-102 2.4 mg gelcap under fasting conditions during the course of the study.
All study subject who were administered one IR tablet of cyclobenzaprine 5 mg under fasting conditions during the course of the study.
All study subject who were administered one TNX-102 2.4 mg, gelcap under fed conditions during the course of the study.
Overall Number of Participants Analyzed 30 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with Treatment-Emergent Adverse Events
14
  46.7%
15
  50.0%
10
  33.3%
Subjects with Serious Adverse Events
0
   0.0%
0
   0.0%
0
   0.0%
Subjects discontinued due to adverse event
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description All study subject who were administered one TNX-102 2.4 mg gelcap under fasting conditions during the course of the study. All study subject who were administered one IR tablet of cyclobenzaprine 5 mg under fasting conditions during the course of the study. All study subject who were administered one TNX-102 2.4 mg gelcap under fed conditions during the course of the study.
All-Cause Mortality
Treatment A Treatment B Treatment C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment A Treatment B Treatment C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment A Treatment B Treatment C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/30 (46.67%)   15/30 (50.00%)   10/30 (33.33%) 
Cardiac disorders       
Palpitations  1  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%) 
Ear and labyrinth disorders       
Ear Discomfort  1  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%) 
Eye disorders       
Photophobia  1  0/30 (0.00%)  1/30 (3.33%)  0/30 (0.00%) 
Gastrointestinal disorders       
Abdominal distension  1  2/30 (6.67%)  0/30 (0.00%)  1/30 (3.33%) 
Constipation  1  3/30 (10.00%)  1/30 (3.33%)  1/30 (3.33%) 
Abdominal Pain  1  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%) 
Diarrhoea  1  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%) 
Nausea  1  0/30 (0.00%)  1/30 (3.33%)  0/30 (0.00%) 
Paraesthesia Oral  1  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%) 
General disorders       
Asthenia  1  0/30 (0.00%)  1/30 (3.33%)  0/30 (0.00%) 
Catheter site erythema  1  0/30 (0.00%)  1/30 (3.33%)  0/30 (0.00%) 
catheter site pain  1  1/30 (3.33%)  0/30 (0.00%)  2/30 (6.67%) 
Vessel puncture site haematoma  1  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%) 
Vessel puncture site reaction  1  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%) 
Infections and infestations       
Rhinitis  1  0/30 (0.00%)  1/30 (3.33%)  0/30 (0.00%) 
Injury, poisoning and procedural complications       
Laceration  1  1/30 (3.33%)  1/30 (3.33%)  0/30 (0.00%) 
Sunburn  1  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%) 
Investigations       
Blood Pressure increased  1  2/30 (6.67%)  1/30 (3.33%)  1/30 (3.33%) 
Heart Rate increased  1  0/30 (0.00%)  1/30 (3.33%)  1/30 (3.33%) 
Mean cell volume increased  1  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%) 
Nervous system disorders       
Somnolence  1  3/30 (10.00%)  11/30 (36.67%)  2/30 (6.67%) 
Headache  1  1/30 (3.33%)  1/30 (3.33%)  1/30 (3.33%) 
Psychiatric disorders       
Nervousness  1  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%) 
Renal and urinary disorders       
Pollakiuria  1  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%) 
Reproductive system and breast disorders       
Dysmenorrhoea  1  0/30 (0.00%)  1/30 (3.33%)  0/30 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%) 
Dry Throat  1  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%) 
Rhinorrhoea  1  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%) 
Vascular disorders       
Hot Flush  1  0/30 (0.00%)  1/30 (3.33%)  0/30 (0.00%) 
1
Term from vocabulary, MedDRA (14.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Greg Sullivan, MD
Organization: Tonix Pharmaceuticals, Inc.
EMail: greg.sullivan@tonixpharma.com
Layout table for additonal information
Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01490788     History of Changes
Other Study ID Numbers: TNX-CY-F101
First Submitted: December 7, 2011
First Posted: December 13, 2011
Results First Submitted: August 8, 2017
Results First Posted: November 2, 2018
Last Update Posted: September 11, 2019