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Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers.

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ClinicalTrials.gov Identifier: NCT03168022
Recruitment Status : Completed
First Posted : May 30, 2017
Results First Posted : July 11, 2019
Last Update Posted : July 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: Other
Condition Healthy Adults
Interventions Drug: Treatment A
Drug: Treatment B
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment A First, Then B Treatment B First, Then A
Hide Arm/Group Description Single Dose of Treatment A (TNX-102 SL 2.8 mg yellow tablet [commercial manufacturer]), Washout 21 days, Single Dose of Treatment B (TNX-102 SL 2.8 mg white tablet [original manufacturer]) Single Dose of Treatment B (TNX-102 SL 2.8 mg white tablet [original manufacturer]), Washout 21 days, Single Dose of Treatment A (TNX-102 SL 2.8 mg yellow tablet [commercial manufacturer])
Period Title: Overall Study
Started 21 22
Completed 21 21
Not Completed 0 1
Arm/Group Title All Study Participants
Hide Arm/Group Description All subjects that were randomized to receive all treatments.
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
<=18 years
0
   0.0%
Between 18 and 65 years
43
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
22
  51.2%
Male
21
  48.8%
1.Primary Outcome
Title Mean Plasma Concentration (AUC) of Cyclobenzaprine
Hide Description 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.
Time Frame 0 to 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed the study and for whom the PK profile could be adequately characterized were included in the outcome measures.
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
All study subjects who were administered one TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) under fasting conditions and completed the study.
All study subject who were administered one TNX-102 SL 2.8 mg white tablet (original manufacturer) under fasting conditions and completed the study.
Overall Number of Participants Analyzed 42 42
Mean (Standard Deviation)
Unit of Measure: pg*h/mL
70066.90  (25158.61) 64711.53  (22633.07)
2.Primary Outcome
Title 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.
Hide Description The MedDRA® dictionary was used to classify all TEAEs reported during the study by System Organ Class (SOC) and Preferred Term (PT).
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
All subjects who received at least one dose of either Treatment A or Treatment comprised the safety population (N = 43). Of these, 1 subject discontinued from the study after one dose of Treatment B and was replaced with a stand-by. A total 42 subjects completed the study as per protocol.
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:

1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved.

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 white tablet (original manufacturer) to be held under the tongue until dissolved.

Treatment B: 1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved.

Overall Number of Participants Analyzed 42 43
Measure Type: Count of Participants
Unit of Measure: Participants
18
  42.9%
19
  44.2%
Time Frame Day 1 up to Day 13.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description All subjects who were administered TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer). All subjects who were administered TNX-102 SL 2.8 mg white yellow tablet (original manufacturer).
All-Cause Mortality
Treatment A Treatment B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/43 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment A Treatment B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/43 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment A Treatment B
Affected / at Risk (%) Affected / at Risk (%)
Total   18/42 (42.86%)   19/43 (44.19%) 
Gastrointestinal disorders     
Hypoaesthesia oral  13/42 (30.95%)  13/43 (30.23%) 
General disorders     
Product taste abnormal  4/42 (9.52%)  5/43 (11.63%) 
Nervous system disorders     
Somnolence  5/42 (11.90%)  4/43 (9.30%) 
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: Gregory Sullivan, MD
Organization: Tonix Pharmaceuticals
EMail: greg.sullivan@tonixpharma.com
Layout table for additonal information
Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03168022     History of Changes
Other Study ID Numbers: TNX-CY-F105
First Submitted: April 25, 2017
First Posted: May 30, 2017
Results First Submitted: January 3, 2018
Results First Posted: July 11, 2019
Last Update Posted: July 11, 2019