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

NCT03168022 | Completed Phase 1 Results FDA Drug

• 1 other identifier: TNX-CY-F105
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, 2-way crossover, single-dose study that is being performed to establish the bioequivalence of TNX-102 SL 2.8 mg tablets from two manufacturers: manufacturer of the Phase 2/3 drug product and manufacturer of the Phase 3 and commercial drug product. This bioequivalence study will confirm (1) the drug product manufactured from these two manufacturers are therapeutically equivalent and (2) the efficacy and safety data obtained in clinical studies using TNX-102 SL from these two manufacturers are comparable.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

• Mean Plasma Concentration (AUC) of Cyclobenzaprine

  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.

  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)

Study Arms (2)

Treatment A

EXPERIMENTAL

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

Drug: Treatment A

Treatment B

EXPERIMENTAL

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

Drug: Treatment B

Interventions

Treatment A DRUG

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

Also known as: cyclobenzaprine HCl

Treatment A

Treatment B DRUG

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

Also known as: cyclobenzaprine HCl

Treatment B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead

Study Sites (1)

InVentiv Health Clinique Inc.

Québec, GIP )A2, Canada

Location

MeSH Terms

Interventions

cyclobenzaprine

Results Point of Contact

• Title: Gregory Sullivan, MD
• Organization: Tonix Pharmaceuticals

greg.sullivan@tonixpharma.com

Study Officials

• Denis Audet, MD

  inVentiv

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 30, 2017
• Study Start: December 16, 2015
• Primary Completion: January 26, 2016
• Study Completion: January 26, 2016
• Last Updated: July 11, 2019
• Results First Posted: July 11, 2019

Record last verified: 2019-04

Locations

CA (1)