Status:
COMPLETED
Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults
Lead Sponsor:
Tonix Pharmaceuticals, Inc.
Conditions:
Healthy Adults
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present ...
Eligibility Criteria
Inclusion
- Healthy adults
- Male or female
- 18-65 years old
- Non-smoker
- BMI \> 18.5 and \< 30.0
- With medically acceptable form of contraception (female only)
- With signed informed consent
Exclusion
- Any clinically significant abnormality including ECG abnormalities or vital sign abnormalities (systolic blood pressure \< 90 or \> 140 mmHg,
- Diastolic blood pressure lower \< 50 or \> 90 mmHg, or heart rate \< 50 or \> 100 BPM)
- Any abnormal laboratory test (including positivity for Hep B, Hep C, HIV, and
- Hemoglobin \< 128 g/L (males) or \< 115 g/L (females) and hematocrit \< 0.37 L/L (males) or \< 0.32 L/L (females))
- 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 :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01889173
Start Date
June 1 2013
End Date
March 1 2014
Last Update
September 26 2014
Active Locations (1)
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1
PharmaNet, Inc.
Québec, Quebec, Canada, G1P 0A2