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

Launched by TONIX PHARMACEUTICALS, INC. · Jun 25, 2013

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.