Status:
COMPLETED
A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.
Lead Sponsor:
Tonix Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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.
Detailed 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, p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 18 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01490788
Start Date
November 18 2011
End Date
December 30 2011
Last Update
September 11 2019
Active Locations (1)
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1
PharmaNet, Inc.
Québec, Quebec, Canada, G1P 0A2