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
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ClinicalTrials.gov Identifier: NCT01889173 |
Recruitment Status :
Completed
First Posted : June 28, 2013
Last Update Posted : September 26, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Adults | Drug: TNX-102 SL Tablets at 2.8 mg Drug: TNX-102-B SL Tablets at 2.8 mg Drug: TNX-102-C SL Tablets at 2.8 mg Drug: Cyclobenzaprine tablets | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Single-Dose, Open-Label, Randomized, Parallel-Design Study Of The Comparative Pharmacokinetics And Safety Of TNX-102 2.8 mg SL Tablets (With Potassium Phosphate) At 2.8 mg, TNX-102-B 2.8 mg SL Tablets (With Sodium Phosphate) At 2.8 mg, TNX-102-C 2.8 mg SL Tablets (With Trisodium Citrate) At 2.8 mg, And Cyclobenzaprine 5 mg Oral Tablets In Healthy Adults |
Study Start Date : | June 2013 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | March 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: TNX-102 SL Tablets at 2.8 mg
1 x TNX-102 SL Tablets (with potassium phosphate) at 2.8 mg
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Drug: TNX-102 SL Tablets at 2.8 mg
1 x TNX-102 SL Tablet (with potassium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it. |
Experimental: TNX-102-B SL Tablets at 2.8 mg
1 x TNX-102-B SL Tablets (with sodium phosphate) at 2.8 mg
|
Drug: TNX-102-B SL Tablets at 2.8 mg
1 x TNX-102-B SL Tablet (with sodium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it. |
Experimental: TNX-102-C SL Tablets at 2.8 mg
1 x TNX-102-C SL Tablets (with trisodium citrate) at 2.8 mg
|
Drug: TNX-102-C SL Tablets at 2.8 mg
1 x TNX-102-C SL Tablet (with trisodium citrate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it. |
Active Comparator: Cyclobenzaprine tablets
1 x 5 mg cyclobenzaprine oral tablet
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Drug: Cyclobenzaprine tablets
1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water |
- Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urine [ Time Frame: 26 time points per period for blood assessment ; 2 pooled analyses in urine. ]Blood samples will be taken per period: within 30 minutes pre-dose and 2, 3.5, 5, 10, 20, 30, and 45 minutes and 1, 2, 2.5, 3, 3.33, 3.67, 4, 4.33, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, and 48 hours post-dose. A single urine sample will be collected within 30 minutes pre-dose (one sample), and urine will be pooled from 0-24 and 24-48 hours post-dose.
- Safety and tolerability of the 3 formulations of TNX-102 SL Tablets at 2.8 mg [ Time Frame: Continuously until the end (day 3) of the study period + Telephone follow-up 7-13 days after dosing (total duration: about 1 month) ]Every adverse events occurring during the study period will be reported.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889173
Canada, Quebec | |
PharmaNet, Inc. | |
Quebec City, Quebec, Canada, G1P 0A2 |
Study Chair: | Seth M. Lederman, MD | Tonix Pharmaceuticals, Inc. | |
Study Director: | Jeffrey P. Kitrelle, MD | Tonix Pharmaceuticals, Inc. | |
Principal Investigator: | Denis Audet, MD | PharmaNet |
Responsible Party: | Tonix Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01889173 History of Changes |
Other Study ID Numbers: |
TNX-CY-F104 |
First Posted: | June 28, 2013 Key Record Dates |
Last Update Posted: | September 26, 2014 |
Last Verified: | September 2014 |
Amitriptyline Cyclobenzaprine Citric Acid Sodium Citrate Potassium phosphate Anticoagulants Calcium Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Muscle Relaxants, Central Physiological Effects of Drugs |
Neuromuscular Agents Peripheral Nervous System Agents Tranquilizing Agents Central Nervous System Depressants Analgesics, Non-Narcotic Analgesics Sensory System Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Adrenergic Agents Neurotransmitter Agents Cariostatic Agents Protective Agents |