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A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.
Phase 1 trial testing Treatment A in Healthy in 30 participants. Completed in 30 December 2011.
| Lead sponsor | Tonix Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 18 November 2011 |
| Primary completion | 30 December 2011 |
| Estimated completion | 30 December 2011 |
| Sites | 1 location across Canada |
Tonix Pharmaceuticals, Inc. — full company profile →
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Blood samples were collected pre-dose, 30 min, 1, 1.5, 2, 2.5, 3, 3.33, 3.67, 4, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose for each treatment period.
| Group | Value | 95% CI |
|---|---|---|
| Treatment A | 47,074.19 | 30288.11 – 63860.27 |
| Treatment B | 94,874.26 | 60588.45 – 129160.07 |
| Treatment C | 50,263.16 | 30725.75 – 69800.57 |
Every adverse events occurring during the study period will be reported.
| Group | Value | 95% CI |
|---|---|---|
| Treatment A | 14 | |
| Treatment B | 15 | |
| Treatment C | 10 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment A | 0 | |
| Treatment B | 0 | |
| Treatment C | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment A | 0 | |
| Treatment B | 0 | |
| Treatment C | 0 |
Time frame: 2 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment A | Treatment B | Treatment C |
|---|---|---|---|---|
| Somnolence | Nervous system disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — |
| Blood Pressure increased | Investigations | — | — | — |
| catheter site pain | General disorders | — | — | — |
| Palpitations | Cardiac disorders | — | — | — |
| Ear Discomfort | Ear and labyrinth disorders | — | — | — |
| Photophobia | Eye disorders | — | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Paraesthesia Oral | Gastrointestinal disorders | — | — | — |
| Asthenia | General disorders | — | — | — |
| Catheter site erythema | General disorders | — | — | — |
| Vessel puncture site haematoma | General disorders | — | — | — |
| Vessel puncture site reaction | General disorders | — | — | — |
| Rhinitis | Infections and infestations | — | — | — |
| Laceration | Injury, poisoning and procedural complications | — | — | — |
| Sunburn | Injury, poisoning and procedural complications | — | — | — |
| Heart Rate increased | Investigations | — | — | — |
| Mean cell volume increased | Investigations | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Nervousness | Psychiatric disorders | — | — | — |
| Pollakiuria | Renal and urinary disorders | — | — | — |
| Dysmenorrhoea | Reproductive system and breast disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Dry Throat | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Hot Flush | Vascular disorders | — | — | — |
Data from ClinicalTrials.gov NCT01490788 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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