Phase 1
Completed N=30
A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.
Healthy
Source: ClinicalTrials.gov NCT01490788 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Mean Plasma Concentration (AUC) of Cyclobenzaprine — 47,074.19; 94,874.26; 50,263.16 pg.hr/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Plasma Concentration (AUC) of Cyclobenzaprine |
47,074.19; 94,874.26; 50,263.16 | — |
| PRIMARY Incidences of Adverse Events |
14; 15; 10; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria: Healthy adults
- Male or female
- Non-smoker
- 18-55 years old
- BMI > 18.5 and 499 mL (within 56 days) prior to dosing.
Data sourced from ClinicalTrials.gov (NCT01490788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.