Title

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

    Phase 1
  • Study Type

    Interventional
  • Intervention/Treatment

    cyclobenzaprine ...
  • Study Participants

    30
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.
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.
Study Started
Nov 18
2011
Primary Completion
Dec 30
2011
Study Completion
Dec 30
2011
Results Posted
Nov 02
2018
Last Update
Sep 11
2019

Drug Treatment C

TNX-102 2.4 mg, 1 gelcap once given under fed conditions.

  • Other names: cyclobenzaprine HCl

Drug Treatment A

TNX-102 2.4 mg - 1 gelcap once under fasting conditions.

  • Other names: cyclobenzaprine HCl

Drug Treatment B

Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions

  • Other names: cyclobenzaprine HCl

Treatment A Experimental

1 x TNX-102 2.4 mg gelcap under fasting conditions

Treatment B Experimental

1 x cyclobenzaprine 5 mg immediate release (IR) tablet under fasting conditions

Treatment C Active Comparator

1 x TNX-102 2.4 mg gelcap under fed conditions

Criteria

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.

Summary

Treatment A

Treatment B

Treatment C

All Events

Event Type Organ System Event Term Treatment A Treatment B Treatment C

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.

Treatment A

Treatment B

Treatment C

Incidences of Adverse Events

Every adverse events occurring during the study period will be reported.

Treatment A

Subjects discontinued due to adverse event

Subjects with Serious Adverse Events

Subjects with Treatment-Emergent Adverse Events

Treatment B

Subjects discontinued due to adverse event

Subjects with Serious Adverse Events

Subjects with Treatment-Emergent Adverse Events

Treatment C

Subjects discontinued due to adverse event

Subjects with Serious Adverse Events

Subjects with Treatment-Emergent Adverse Events

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

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