At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Treatment A +2 moredrug
Likely dose
Treatment A 2.4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Dose, Open-Label, Randomized, Three-Way Crossover Study of the Comparative Bioavailability of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets and of the Effect of Food on the Pharmacokinetics of TNX-102 2.4 mg in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating Treatment A, Treatment B, and 1 other intervention for Healthy. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedDec 2011
Primary CompletionDec 2011
TodayJul 2026
First PostedDec 13, 2011
Enrollment StartNov 18, 2011
Primary CompletionDec 30, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.6 years ago
Interventions
Treatment Adrug
TNX-102 2.4 mg - 1 gelcap once under fasting conditions.
Treatment Bdrug
Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions
Treatment Cdrug
TNX-102 2.4 mg, 1 gelcap once given under fed conditions.