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

Healthy Clinical Trial

Official title:

A Single-Dose, Open-Label, Randomized, Three-Way Crossover Study of the Comparative Bioavailability of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets and of the Effect of Food on the Pharmacokinetics of TNX-102 2.4 mg in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490788
• Other study ID #: TNX-CY-F101
• Status: Completed
• Phase: Phase 1
• Start date: November 18, 2011
• Est. completion date: December 30, 2011

Study information

• Verified date: September 2019
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Description:

Single-center, randomized, open-label, single-dose, three-way-crossover trial is designed to assess the safety and tolerability of TNX-102 2.4 mg (a dose based on the results of a previous Phase 2a, proof-of-concept study - VPI-CY-0001.1) and to compare the rate and extent of absorption of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2011
• Est. primary completion date: December 30, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria: Healthy adults

• Male or female

• Non-smoker

• 18-55 years old

• BMI > 18.5 and < 30.0

• With medically acceptable form of contraception (female only).

Exclusion Criteria:

• Any clinically significant abnormality or vital sign abnormalities

• Any abnormal laboratory test

• History of alcohol or drug abuse or dependence within 1 year and/or positive drug, cotinine, or alcohol tests

• Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce or inhibit hepatic drug metabolism prior to study medication

• Positive pregnancy test, breastfeeding or lactating

• Use of medication other than hormonal contraceptives or topical products, including OTC, natural health products, MAO inhibitors

• Participation in an investigational study within 30 days prior to dosing

• Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within 30 days), or of > 499 mL (within 56 days) prior to dosing.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Treatment A
TNX-102 2.4 mg - 1 gelcap once under fasting conditions.
• Treatment B
Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions
• Treatment C
TNX-102 2.4 mg, 1 gelcap once given under fed conditions.

Locations

Country	Name	City	State
Canada	PharmaNet, Inc.	Québec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Tonix Pharmaceuticals, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Plasma Concentration (AUC) of Cyclobenzaprine	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.	0 to 96 hours
Primary	Incidences of Adverse Events	Every adverse events occurring during the study period will be reported.	Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month)