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

• Status: Completed
• Trial end date: 2011-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tonix Pharmaceuticals, Inc.
• Treatments: Amitriptyline; Cyclobenzaprine

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.